TPLC - Total Product Life Cycle

• Device: electrosurgical, cutting & coagulation & accessories
• Regulation Description: Electrosurgical cutting and coagulation device and accessories.
• Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
• Product Code: GEI
• Regulation Number: 878.4400
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ACOTEC SCIENTIFIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
AERIN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
AESTHETIC MANAGEMENT PARTNERS
	SUBSTANTIALLY EQUIVALENT	1
AESTHETICS BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	1
AGNES MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	6
ALIC IOTECH, LLC
	SUBSTANTIALLY EQUIVALENT	1
ALMA LASERS, INC.
	SUBSTANTIALLY EQUIVALENT	1
APPLIED MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
APPLIED MEDICAL RESOURCES CORP.
	SUBSTANTIALLY EQUIVALENT	1
APPLIED MEDICAL RESOURCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
APYX MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
APYX MEDICAL CORPORATION (FORMERLY BOVIE MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
APYX MEDICAL CORPORATION(FORMERLY BOVIE MEDICAL CORPORATION)
	SUBSTANTIALLY EQUIVALENT	1
ARTHROCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	7
ASCBLUE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ASTERASYS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ATRAVERSE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
AUGUSTINE TEMPERATURE MANAGEMENT, LLC
	SUBSTANTIALLY EQUIVALENT	1
AVENTIX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
AXON SPINE MEDICAL SYSTEM
	SUBSTANTIALLY EQUIVALENT	1
BAISHENG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
BAYLIS MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING TAKTVOLL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIOS S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
BOLDER SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	4
BOMTECH ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON AESTHETICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
BRERA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BTL
	SUBSTANTIALLY EQUIVALENT	1
BTL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	8
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
C2DX, INC.
	SUBSTANTIALLY EQUIVALENT	1
CANDELA CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
CELLAH MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHUNGWOO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
CINTRON MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CLASSYS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CNC TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
CNS MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
COMPAL ELECTRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
COMPEX, SPOL, S.R.O.
	SUBSTANTIALLY EQUIVALENT	1
CONMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	5
COVIDIEN, LLC
	SUBSTANTIALLY EQUIVALENT	6
CREO MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
CROSS VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
CUTERA, INC.
	SUBSTANTIALLY EQUIVALENT	2
CYNOSURE, LLC
	SUBSTANTIALLY EQUIVALENT	2
DANNIK, LLC
	SUBSTANTIALLY EQUIVALENT	2
DELTRONIX EQUIPAMENTOS LTDA
	SUBSTANTIALLY EQUIVALENT	1
DEX SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN QUANDING MEDICAL SUPPLIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
E SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ELLUSA, LLC
	SUBSTANTIALLY EQUIVALENT	2
ENDYMED MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ENERGIST LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ENTIRE MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	2
ERBE ELEKTROMEDIZIN GMBH
	SUBSTANTIALLY EQUIVALENT	7
ETHICON ENDO-SURGERY, LLC
	SUBSTANTIALLY EQUIVALENT	3
ETHICON ENDO-SURGERY, LLC (A JOHNSON AND JOHNSON COMPANY)
	SUBSTANTIALLY EQUIVALENT	1
EUNSUNG GLOBAL CORP
	SUBSTANTIALLY EQUIVALENT	1
EXCELSIOR RESOURCES, LLC
	SUBSTANTIALLY EQUIVALENT	1
F CARE SYSTEMS USA, LLC
	SUBSTANTIALLY EQUIVALENT	3
GMV S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU AIMIRA INNOVATION TECHNOLOGY CO, LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUENTER BISSINGER MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
GYRUS ACMI, INC.
	SUBSTANTIALLY EQUIVALENT	3
H.S HOSPITAL SERVICE S.P.A
	SUBSTANTIALLY EQUIVALENT	1
HG INNOVATIONS, LTD.
	SUBSTANTIALLY EQUIVALENT	3
HIRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
HOOGLAND SPINE PRODUCTS, GMBH
	SUBSTANTIALLY EQUIVALENT	1
ILOODA CO,., LTD.
	SUBSTANTIALLY EQUIVALENT	4
INBELLA MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
INBELLA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
INDIBA S. A. U.
	SUBSTANTIALLY EQUIVALENT	1
INMODE , LTD.
	SUBSTANTIALLY EQUIVALENT	6
INMODE MD , LTD.
	SUBSTANTIALLY EQUIVALENT	1
INNOBLATIVE DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA MICROFRANCE
	SUBSTANTIALLY EQUIVALENT	1
INTELIS INSTRUMENTS , LTD.
	SUBSTANTIALLY EQUIVALENT	1
INTUITIVE SURGICAL
	SUBSTANTIALLY EQUIVALENT	4
ITALIAN ENGINEERING S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
JEISYS MEDICAL INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
JEISYS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
JIANGSU BONSS MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU HAIZE MEDICAL SCIENTIFIC DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU HOPE BIOMEDICAL SCIENCE & TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
JIANGSU RONG FU KANG MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KATALYST SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
KIRWAN SURGICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
LAGIS ENTERPRISE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LED SPA
	SUBSTANTIALLY EQUIVALENT	1
LINA MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	1
LIVSMED, INC.
	SUBSTANTIALLY EQUIVALENT	8
LUMENIS BE, LTD.
	SUBSTANTIALLY EQUIVALENT	1
LUTRONIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MAQUET CARDIOVASCULAR, LLC
	SUBSTANTIALLY EQUIVALENT	3
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEGADYNE MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICROLINE SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
MODERN MEDICAL EQUIPMENT MANUFACTURING, LTD.
	SUBSTANTIALLY EQUIVALENT	2
NEAUVIA NORTH AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	2
NEURENT MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
NEURENT MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
NEW DEANTRONICS TAIWAN , LTD.
	SUBSTANTIALLY EQUIVALENT	1
NINGBO SHUN YE MEDICAL COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
NISSHA MEDICAL TECHNOLOGIES, LTD.
	SUBSTANTIALLY EQUIVALENT	1
NOVOXEL , LTD.
	SUBSTANTIALLY EQUIVALENT	2
OLYMPUS MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS WINTER & IBE GMBH
	SUBSTANTIALLY EQUIVALENT	5
PLASMA SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
POLLOGEN, LTD.
	SUBSTANTIALLY EQUIVALENT	5
PRANA SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
PULSE BIOSCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	7
REBOUND THERAPEUTICS
	SUBSTANTIALLY EQUIVALENT	1
RELIGN CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
RELIGN CORPORATION, SUBSIDIARY OF ZIMMER BIOMET
	SUBSTANTIALLY EQUIVALENT	1
RF MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ROHRER AESTHETICS
	SUBSTANTIALLY EQUIVALENT	1
ROHRER AESTHETICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
SAFER SURGERIES MEDICAL DEVICES, LLC
	SUBSTANTIALLY EQUIVALENT	1
SCITON, INC
	SUBSTANTIALLY EQUIVALENT	1
SEJONG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENB CO., LTD.
	SUBSTANTIALLY EQUIVALENT	7
SHENZHEN GSD TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MECUN MEDICAL SUPPLY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN PENINSULA MEDICAL GROUP
	SUBSTANTIALLY EQUIVALENT	1
SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHINING WORLD HEALTH CARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SINGLE PASS, INC.
	SUBSTANTIALLY EQUIVALENT	2
SKINGRAB CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SONIQUENCE, LLC
	SUBSTANTIALLY EQUIVALENT	4
STARMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
STERIS
	SUBSTANTIALLY EQUIVALENT	2
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
STRYKER INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	3
STRYKER SUSTAINABILITY SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	2
SURGICAL PRINCIPALS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SURNIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SUTTER MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	2
TENTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
TITAN MANUFACTURING, INC.
	SUBSTANTIALLY EQUIVALENT	1
TRIWORKS GROUP SRL
	SUBSTANTIALLY EQUIVALENT	1
VENCLOSE, INC.
	SUBSTANTIALLY EQUIVALENT	3
VENUS CONCEPT, INC.
	SUBSTANTIALLY EQUIVALENT	1
VHMED (NANTONG) CO. , LTD.
	SUBSTANTIALLY EQUIVALENT	1
VIGEON TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VIOL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
VIVEVE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
VIVEVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
WE MEDICAL TECHNOLOGY (WUXI) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WICKIMED (HUIZHOU) MEDICAL EQUIPMENT MANUFACTURING CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
WONTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
ZHEJIANG CURAWAY MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	6354	6367
2022	6103	6145
2023	7176	7184
2024	7897	7900
2025	7696	7696
2026	3069	3069

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	4015	4024
Break	3866	3874
Detachment of Device or Device Component	3075	3086
Energy Output Problem	2975	2977
Electrical /Electronic Property Problem	2268	2269
Difficult to Open or Close	1995	1995
Peeled/Delaminated	1866	1866
Output Problem	1289	1293
Communication or Transmission Problem	1184	1184
Material Twisted/Bent	867	867
Self-Activation or Keying	857	858
Insufficient Information	787	787
Failure to Deliver Energy	744	744
Mechanical Problem	733	736
Device Displays Incorrect Message	725	726
Retraction Problem	679	679
Infusion or Flow Problem	657	658
Intermittent Energy Output	648	651
Overheating of Device	646	646
Device Alarm System	635	638
Material Separation	601	601
Failure to Cut	598	598
Appropriate Term/Code Not Available	571	571
Connection Problem	570	572
Fracture	533	533
Material Fragmentation	523	523
Application Program Problem: Parameter Calculation Error	521	521
Sparking	509	512
Use of Device Problem	478	478
Activation Problem	464	464
Melted	462	462
Fire	444	450
Delivered as Unsterile Product	424	424
Device Remains Activated	398	398
No Apparent Adverse Event	380	380
Protective Measures Problem	365	365
Electrical Shorting	359	359
Material Integrity Problem	346	346
Smoking	301	301
Arcing	296	298
Unintended Power Up	283	283
Degraded	265	265
Defective Device	254	258
Mechanical Jam	241	242
Patient Device Interaction Problem	221	221
Activation Failure	214	214
Continuous Firing	213	213
Failure to Seal	206	206
Fitting Problem	204	204
Material Deformation	195	195

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	28905	28943
Insufficient Information	2650	2664
Burn(s)	1888	1890
Hemorrhage/Bleeding	1853	1853
Superficial (First Degree) Burn	593	594
Partial thickness (Second Degree) Burn	510	511
Foreign Body In Patient	475	477
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	389	393
Full thickness (Third Degree) Burn	307	307
Unspecified Tissue Injury	305	305
Pain	249	251
No Consequences Or Impact To Patient	242	242
Blister	214	214
Erythema	196	196
Hematoma	168	168
Scar Tissue	163	163
Thrombosis/Thrombus	161	161
Unspecified Infection	130	130
Electric Shock	122	122
Laceration(s)	110	110
Swelling/ Edema	100	100
Perforation	82	82
Unintended Radiation Exposure	80	80
Necrosis	75	75
Tissue Breakdown	75	75
Bowel Perforation	74	74
Skin Inflammation/ Irritation	71	71
Skin Discoloration	69	69
Nerve Damage	60	60
Bowel Burn	55	55
Abscess	53	53
Post Operative Wound Infection	50	50
Fistula	47	47
Pneumothorax	47	47
Epistaxis	47	47
Fever	45	45
Internal Organ Perforation	43	43
Bruise/Contusion	43	43
Inflammation	41	41
Abdominal Pain	40	40
Phlebitis	40	40
Deformity/ Disfigurement	40	40
Pleural Effusion	39	39
Numbness	36	36
Skin Tears	35	35
No Patient Involvement	33	33
Stenosis	32	32
Ecchymosis	32	32
Localized Skin Lesion	32	32
Tachycardia	31	31

Recalls
Manufacturer		Recall Class	Date Posted
1	Aerin Medical, Inc.	II	Jan-06-2025
2	Aesculap Implant Systems LLC	II	May-05-2023
3	Aomori Olympus Co., Ltd.	II	Feb-05-2021
4	Bard Peripheral Vascular Inc	II	Sep-26-2025
5	Bard Peripheral Vascular Inc	II	Nov-13-2024
6	Beaver Visitec International, Inc.	II	Jun-23-2022
7	Bolder Surgical, LLC	II	Mar-08-2022
8	Bovie Medical Corporation	II	Feb-26-2021
9	Carefusion 2200 Inc	II	Dec-03-2022
10	ConMed Corporation	II	Dec-09-2022
11	CooperSurgical, Inc.	II	Jun-10-2021
12	Covidien	II	Jan-03-2024
13	Covidien	II	Apr-12-2021
14	Covidien Llc	II	Jan-13-2022
15	Intuitive Surgical, Inc.	II	May-31-2022
16	Kirwan Surgical Products, LLC	I	Dec-16-2024
17	Lutronic Corporation	II	Oct-14-2025
18	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-09-2025
19	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
20	Maquet Cardiovascular, LLC	II	Sep-25-2025
21	Maquet Cardiovascular, LLC	II	Apr-18-2025
22	Maquet Cardiovascular, LLC	II	Apr-16-2025
23	Maquet Cardiovascular, LLC	I	Jan-03-2025
24	Maquet Cardiovascular, LLC	I	Oct-25-2024
25	Maquet Cardiovascular, LLC	II	Jul-11-2024
26	Maquet Cardiovascular, LLC	II	Jun-24-2024
27	Maquet Cardiovascular, LLC	II	Jan-12-2024
28	Maquet Cardiovascular, LLC	II	Nov-02-2023
29	Maquet Cardiovascular, LLC	II	Apr-04-2023
30	Maquet Cardiovascular, LLC	II	Jan-19-2023
31	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
32	Megadyne Medical Products, Inc.	I	Jul-03-2024
33	Megadyne Medical Products, Inc.	I	Jun-06-2024
34	Megadyne Medical Products, Inc.	I	Dec-26-2023
35	Megadyne Medical Products, Inc.	II	Jul-28-2023
36	Megadyne Medical Products, Inc.	I	Jun-30-2023
37	Microline Surgical, Inc.	II	Dec-10-2024
38	Nico Corp.	II	Jun-09-2021
39	Olympus Corporation of the Americas	II	Apr-17-2026
40	Olympus Corporation of the Americas	II	Mar-25-2026
41	Olympus Corporation of the Americas	II	Aug-19-2025
42	Olympus Corporation of the Americas	II	Oct-30-2024
43	Olympus Corporation of the Americas	II	Aug-08-2024
44	Olympus Corporation of the Americas	II	Jul-23-2024
45	Olympus Corporation of the Americas	II	Apr-30-2024
46	Olympus Corporation of the Americas	II	Feb-20-2024
47	Olympus Corporation of the Americas	II	Sep-26-2022
48	Olympus Corporation of the Americas	II	Aug-27-2021
49	Silex Medical, LLC	II	Jun-02-2025
50	Solta Medical Inc	II	Apr-07-2023
51	Steris Corporation	II	Nov-16-2022
52	Stryker Corporation	II	Nov-26-2025
53	Stryker Corporation	II	Feb-11-2025
54	Stryker Corporation	II	Jan-06-2025
55	Stryker Corporation	II	Nov-13-2024
56	Stryker Corporation	II	Nov-07-2023
57	Zimmer, Inc.	II	Nov-01-2024