|
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 |
ADEOR MEDICAL AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AERIN MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AERIN MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AERIN MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AESCULAP INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AESTHETIC MANAGEMENT PARTNERS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AESTHETICS BIOMEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AGNES MEDICAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ALIC IOTECH, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALMA LASERS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APPLIED MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APPLIED MEDICAL RESOURCES CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
APPLIED MEDICAL RESOURCES CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
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
|
6
|
AUCKLAND MEDICAL POLYMER(TIANJIN) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AUGUSTINE TEMPERATURE MANAGEMENT LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AXON SPINE MEDICAL SYSTEM |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAISHENG MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BEIJING TAKTVOLL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOS S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIPAD SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOLDER SURGICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BOLDER SURGICAL, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOMTECH ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOWA-ELECTRONICS GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BRERA MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BTL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BTL INDUSTRIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
BTL INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
C.R. BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C2DX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAMBRIDGE INTERVENTIONAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CANDELA CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CARTESSA AESTHETICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHUNGWOO CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CLASSYS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CNC TECHNOLOGIES |
|
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
|
5
|
COVIDIEN, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CREO MEDICAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CROSS VASCULAR INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CUTERA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CYNOSURE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CYNOSURE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DANNIK |
|
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
|
4
|
ENCISION INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENCISION INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENERGIST LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ERBE ELEKTROMEDIZIN GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ETHICON ENDO-SURGERY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ETHICON ENDO-SURGERY, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
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
|
1
|
FHC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FULWELL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
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
|
2
|
HG INNOVATIONS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HIRONIC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HIRONIC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HOOGLAND SPINE PRODUCTS, GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HS HOSPITAL SERVICE SPA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ILOODA CO,.LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ILOODA CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
INBELLA MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INDIBA S.A.U |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INMODE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
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
|
INVUITY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ITALIAN ENGINEERING SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JEISYS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
JEISYS MEDICAL INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JEISYS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
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
|
1
|
JIANGSU HOPE BIOMEDICAL SCIENCE&TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU RONG FU KANG MEDICAL INSTRUMENTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KATALYST SURGICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KIRWAN SURGICAL PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LED SPA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LINA MEDICAL APS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIVSMED INC. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
MAQUET CARDIOVASCULAR, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTIRES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, LP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDRANGE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC NAVIGATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC SOFAMOR DANEK USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEGADYNE MEDICAL PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MICRO-TECH (NANJING) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MICROLINE SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MODERN MEDICAL EQUIPMENT MANUFACTURING, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
NEAUVIA NORTH AMERICA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NEURENT MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEW DEANTRONICS TAIWAN LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
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 CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS SURGICAL TECHNOLOGIES AMERICA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS WINTER & IBE GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PAVMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POLLOGEN LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POLLOGEN LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PULSE BIOSCIENCES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
REBOUND THERAPEUTICS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RELIGN CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RELIGN CORPORATION, SUBSIDIARY OF ZIMMER BIOMET |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RF MEDICAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
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
|
1
|
SHENB CO LTD |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SHENB CO LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENB CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MECUN MEDICAL SUPPLY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHINING WORLD HEALTH CARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SINGLE PASS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SKINGRAB CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SONIQUENCE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
STARMED CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
STERIS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER INSTRUMENTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
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
|
2
|
UNITED STATES ENDOSCOPY GROUP, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VENCLOSE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VENUS CONCEPT USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VHMED (NANTONG) CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VIOL CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VIOL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VIVEVE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
VIVEVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WICKIMED (HUIZHOU) MEDICAL EQUIPMENT MANUFACTURING CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WON TECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ZHEJIANG CURAWAY MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
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 |
Nov-13-2024 |
5 |
Beaver Visitec International, Inc. |
II |
Jun-23-2022 |
6 |
Bolder Surgical, LLC |
II |
Mar-08-2022 |
7 |
Boston Scientific Corporation |
II |
Dec-22-2020 |
8 |
Bovie Medical Corporation |
II |
Feb-26-2021 |
9 |
Bovie Medical Corporation |
II |
May-20-2020 |
10 |
Carefusion 2200 Inc |
II |
Dec-03-2022 |
11 |
ConMed Corporation |
II |
Dec-09-2022 |
12 |
CooperSurgical, Inc. |
II |
Jun-10-2021 |
13 |
Covidien |
II |
Jan-03-2024 |
14 |
Covidien |
II |
Apr-12-2021 |
15 |
Covidien Llc |
II |
Jan-13-2022 |
16 |
Covidien Llc |
II |
Feb-25-2020 |
17 |
Intuitive Surgical, Inc. |
II |
May-31-2022 |
18 |
Kirwan Surgical Products, LLC |
I |
Dec-16-2024 |
19 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Sep-06-2024 |
20 |
Maquet Cardiovascular, LLC |
I |
Jan-03-2025 |
21 |
Maquet Cardiovascular, LLC |
I |
Oct-25-2024 |
22 |
Maquet Cardiovascular, LLC |
II |
Jul-11-2024 |
23 |
Maquet Cardiovascular, LLC |
II |
Jun-24-2024 |
24 |
Maquet Cardiovascular, LLC |
II |
Jan-12-2024 |
25 |
Maquet Cardiovascular, LLC |
II |
Nov-02-2023 |
26 |
Maquet Cardiovascular, LLC |
II |
Apr-04-2023 |
27 |
Maquet Cardiovascular, LLC |
II |
Jan-19-2023 |
28 |
Mckesson Medical-Surgical Inc. Corporate Office |
II |
Aug-26-2022 |
29 |
Megadyne Medical Products, Inc. |
I |
Jul-03-2024 |
30 |
Megadyne Medical Products, Inc. |
I |
Jun-06-2024 |
31 |
Megadyne Medical Products, Inc. |
I |
Dec-26-2023 |
32 |
Megadyne Medical Products, Inc. |
II |
Jul-28-2023 |
33 |
Megadyne Medical Products, Inc. |
I |
Jun-30-2023 |
34 |
Microline Surgical, Inc. |
II |
Dec-10-2024 |
35 |
Nico Corp. |
II |
Jun-09-2021 |
36 |
Olympus Corporation of the Americas |
II |
Oct-30-2024 |
37 |
Olympus Corporation of the Americas |
II |
Aug-08-2024 |
38 |
Olympus Corporation of the Americas |
II |
Jul-23-2024 |
39 |
Olympus Corporation of the Americas |
II |
Apr-30-2024 |
40 |
Olympus Corporation of the Americas |
II |
Feb-20-2024 |
41 |
Olympus Corporation of the Americas |
II |
Sep-26-2022 |
42 |
Olympus Corporation of the Americas |
II |
Aug-27-2021 |
43 |
Solta Medical Inc |
II |
Apr-07-2023 |
44 |
Solta Medical Inc |
II |
Apr-07-2020 |
45 |
Steris Corporation |
II |
Nov-16-2022 |
46 |
Stryker Corporation |
II |
Feb-11-2025 |
47 |
Stryker Corporation |
II |
Jan-06-2025 |
48 |
Stryker Corporation |
II |
Nov-13-2024 |
49 |
Stryker Corporation |
II |
Nov-07-2023 |
50 |
Stryker Corporation |
II |
Mar-17-2020 |
51 |
Stryker Instruments Div. of Stryker Corporation |
II |
Apr-28-2020 |
52 |
Stryker Instruments Div. of Stryker Corporation |
II |
Jan-28-2020 |
53 |
Sutter Medizintechnik GmbH |
II |
Jul-31-2020 |
54 |
Zimmer, Inc. |
II |
Nov-01-2024 |
|
|
|
|