TPLC - Total Product Life Cycle

• Device: electrosurgical, cutting & coagulation & accessories
• Regulation Description: Electrosurgical cutting and coagulation device and accessories.
• Product Code: GEI
• Regulation Number: 878.4400
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	5
A&E
	SUBSTANTIALLY EQUIVALENT	6
AARON MEDICAL
	SUBSTANTIALLY EQUIVALENT	27
ACMI CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
AESCULAP
	SUBSTANTIALLY EQUIVALENT	12
ALLIANCE MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
ALMA LASERS LTD.
	SUBSTANTIALLY EQUIVALENT	2
ALPHA SOURCE, INC
	SUBSTANTIALLY EQUIVALENT	2
AMERICAN BIOSURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
AMERICAN MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ANGIODYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
APPLIED MEDICAL RESOURCES CORP.
	SUBSTANTIALLY EQUIVALENT	3
ARAGON SURGICAL INC.
	SUBSTANTIALLY EQUIVALENT	4
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARTHROCARE CORP.
	SUBSTANTIALLY EQUIVALENT	66
ASCENT HEALTHCARE SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
ASPEN LABORATORIES
	SUBSTANTIALLY EQUIVALENT	26
ASPEN SURGICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ATRICURE, INC.
	SUBSTANTIALLY EQUIVALENT	4
BALLARD MEDICAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
BARRX MEDICAL, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	15
BAYLIS MEDICAL CO., INC.
	SUBSTANTIALLY EQUIVALENT	6
BEI MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
BERCHTOLD CORP.
	SUBSTANTIALLY EQUIVALENT	4
BIO PROTECH, INC.
	SUBSTANTIALLY EQUIVALENT	3
BIO-MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
BLACK & BLACK SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	15
BOVIE
	SUBSTANTIALLY EQUIVALENT	8
BYRON MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	11
CAMERON-MILLER, INC.
	SUBSTANTIALLY EQUIVALENT	10
CARDINAL HEALTH
	SUBSTANTIALLY EQUIVALENT	3
CELON AG MEDICAL INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	2
CODMAN & SHURTLEFF, INC.
	SUBSTANTIALLY EQUIVALENT	5
CONMED
	SUBSTANTIALLY EQUIVALENT	55
CONTOUR FABRICATORS, INC.
	SUBSTANTIALLY EQUIVALENT	1
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	5
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	4
CRYOGEN, INC.
	SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS	1
CURON MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
DEPUY INTL., LTD.
	SUBSTANTIALLY EQUIVALENT	5
DEROYAL
	SUBSTANTIALLY EQUIVALENT	2
ELECTROMEDICS CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
ELLMAN INT'L INC.
	SUBSTANTIALLY EQUIVALENT	18
ELMED
	SUBSTANTIALLY EQUIVALENT	6
EMCISION, LTD.
	SUBSTANTIALLY EQUIVALENT	5
ENCISION, INC.
	SUBSTANTIALLY EQUIVALENT	6
ENDIUS, INC.
	SUBSTANTIALLY EQUIVALENT	2
ENDOCARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENDYMION MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
ERBE ELEKTROMEDIZIN GMBH
	SUBSTANTIALLY EQUIVALENT	25
ETHICON
	SUBSTANTIALLY EQUIVALENT	21
FUSION MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
GALIL MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
GENICON
	SUBSTANTIALLY EQUIVALENT	2
GUIDANT CORP
	SUBSTANTIALLY EQUIVALENT	3
GYRUS ACMI, INC.
	SUBSTANTIALLY EQUIVALENT	25
HALT MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
HEARTPORT, INC.
	SUBSTANTIALLY EQUIVALENT	1
HOGAN & HARTSON L.L.P.
	SUBSTANTIALLY EQUIVALENT	1
I.C. MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	5
INTERMEDICS
	SUBSTANTIALLY EQUIVALENT	2
INTUITIVE SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
INVASIX LTD.
	SUBSTANTIALLY EQUIVALENT	1
ION MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ISKRA MEDICAL, D.O.O.
	SUBSTANTIALLY EQUIVALENT	1
J. JAMNER
	SUBSTANTIALLY EQUIVALENT	2
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	5
KARL STORZ GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	12
KIRWAN SURGICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	10
KLS MARTIN GMBH + CO. KG
	SUBSTANTIALLY EQUIVALENT	1
LEONHARD LANG GMBH
	SUBSTANTIALLY EQUIVALENT	2
LINA MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	1
LINEMASTER SWITCH CORP.
	SUBSTANTIALLY EQUIVALENT	1
LINVATEC
	SUBSTANTIALLY EQUIVALENT	6
LIVE TISSUE CONNECT, INC.
	SUBSTANTIALLY EQUIVALENT	1
LUMENIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MAQUET, INC.
	SUBSTANTIALLY EQUIVALENT	2
MAXXIM MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
MECTRA LABS, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MEDISISS
	SUBSTANTIALLY EQUIVALENT	2
MEDLINE
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	11
MEGADYNE MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	27
MICROLINE PENTAX, INC.
	SUBSTANTIALLY EQUIVALENT	7
MINI LAP TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1
MISONIX, INC.
	SUBSTANTIALLY EQUIVALENT	1
MITEK
	SUBSTANTIALLY EQUIVALENT	4
MODERN MEDICAL EQUIPMENT MFG., LTD.
	SUBSTANTIALLY EQUIVALENT	8
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	2
NCONTACT SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEOMEDIX CORP.
	SUBSTANTIALLY EQUIVALENT	3
NEOTHERMIA
	SUBSTANTIALLY EQUIVALENT	6
NEW DEANTRONICS TAIWAN, LTD.
	SUBSTANTIALLY EQUIVALENT	6
NORTHGATE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
NOVASYS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
OLSEN MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
OLYMPUS
	SUBSTANTIALLY EQUIVALENT	9
ORTHO DEVELOPMENT
	SUBSTANTIALLY EQUIVALENT	2
ORTHOPEDIC SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
PAJUNK GMBH
	SUBSTANTIALLY EQUIVALENT	3
PATTON SURGICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
PEAK SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	7
PILLING WECK
	SUBSTANTIALLY EQUIVALENT	2
PIONEER
	SUBSTANTIALLY EQUIVALENT	1
POREX SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRO-MED INSTRUMENTS GMBH
	SUBSTANTIALLY EQUIVALENT	1
Q2 MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
RADIOTHERAPEUTICS
	SE-SPECIAL LABELING	1
	SUBSTANTIALLY EQUIVALENT	9
RHYTEC
	SUBSTANTIALLY EQUIVALENT	5
RICHARD WOLF
	SUBSTANTIALLY EQUIVALENT	11
RITA MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	14
RUBICOR MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	6
RUDOLF STORZ GMBH
	SUBSTANTIALLY EQUIVALENT	1
RZ MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
SALIENT TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
SENORX, INC.
	SUBSTANTIALLY EQUIVALENT	6
SIEMENS
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	31
SOLOS ENDOSCOPY, INC
	SUBSTANTIALLY EQUIVALENT	4
SOMNUS MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	16
SORIN
	SUBSTANTIALLY EQUIVALENT	1
STARION INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	6
STELLARTECH RESEARCH CORP.
	SUBSTANTIALLY EQUIVALENT	11
STERILMED
	SUBSTANTIALLY EQUIVALENT	1
STINGRAY SURGICAL PRODUCTS, INC
	SUBSTANTIALLY EQUIVALENT	2
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	16
SURGICAL LASER TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
SURGRX, INC.
	SUBSTANTIALLY EQUIVALENT	8
SUTTER MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
Symbiosis Corp.
	SUBSTANTIALLY EQUIVALENT	5
SYNERGETICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
SYNERON
	SUBSTANTIALLY EQUIVALENT	2
TECNO INSTRUMENTS (PVT.) LTD.
	SUBSTANTIALLY EQUIVALENT	2
THE ANSPACH EFFORT, INC.
	SUBSTANTIALLY EQUIVALENT	1
THERMAGE, INC.
	SUBSTANTIALLY EQUIVALENT	17
THERMOSURGERY TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
TISSUELINK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	12
TRANSAMERICAN TECHNOLOGIES INTL.
	SUBSTANTIALLY EQUIVALENT	1
TROD MEDICAL SA
	SUBSTANTIALLY EQUIVALENT	1
TROKAMED GMBH
	SUBSTANTIALLY EQUIVALENT	1
ULTHERA, INC.
	CLEARED FOR MARKETING AUTOMATIC CLASS III DESIGNAT	1
UNITED STATES SURGICAL
	SUBSTANTIALLY EQUIVALENT	5
UTAH MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	3
VALLEYLAB
	SUBSTANTIALLY EQUIVALENT	71
VANGUARD MEDICAL CONCEPTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
VIDAMED, INC.
	SUBSTANTIALLY EQUIVALENT	7
VNUS MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	9
W. LORENZ SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
WALLACH SURGICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	3
WARNER-LAMBERT CO.
	SUBSTANTIALLY EQUIVALENT	1
XODUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
XOMED, INC.
	SUBSTANTIALLY EQUIVALENT	3
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	4

Device Problems
Device displays error message	397
Unknown (for use when the device problem is not known)	369
Other (for use when an appropriate device code cannot be identified)	334
Tip breakage	279
Break	249
Detachment of device component	245
Replace	239
Device inoperable	189
No Known Device Problem	175
Component(s), broken	145
Device remains activated	123
Device Issue	117
Failure to deliver energy	113
Device operates differently than expected	82
No code available	66
Component(s), overheating of	60
Self-activation or keying	58
Dislodged or dislocated	51
Burn of device or device component	49
Peeled	47
Inflation issue	47
Crack	42
Retraction problem	34
Therapeutic or diagnostic output failure	33
Detachment of device or device component	32
No Information	30
Component falling	30
Overheating of device or device component	29
Mechanical issue	28
Bent	27
Difficult to open or close	22
Failure to cut	19
Smoking	18
Loss of power	17
System fails to activate	16
Electrical issue	16
Melted	15
Device, removal of (non-implant)	15
Fracture	14
Noise	14
Use of Device Issue	14
Malfunction	14
Biofilm coating in device	13
Spark	13
Difficult to remove	12
Balloon burst	12
Device or device fragments location unknown	11
Alarm, error of warning	11
Error or warning message, failure to produce	11
Arcing	10
Energy output to patient tissue incorrect	9
Intermittent continuity	9
Difficult or delayed activation	9
Output issue	8
Device, or device fragments remain in patient	8
Failure to power-up	8
Tears, rips, holes in device, device material	8
Foreign material present in device	8
Sticking	8
Normal	7
Physical resistance	7
Material fragmentation	7
Fire	7
Alarm, audible	7
Output, high	6
Defective component	6
No device output	6
Loss of or failure to bond	6
No display or display failure	5
Output, low	5
Defective item	5
Failure to align	5
Material perforation	5
Dull	5
Difficult to deploy	5
Failure to conduct	5
Failure, intermittent	5
Device stops intermittently	5
Loose	5
Mechanical jam	5
Failure to separate	4
Failure to deploy	4
Material discolored	4
Shock, electrical	4
Valve(s), failure of	4
Sharp/jagged/rough/etched/scratched	4
Difficult to insert	4
Temperature issue	4
Component missing	3
Slippage of device or device component	3
Cautery	3
Insulation, detached	3
Material frayed	3
Grounding malfunction	3
Loose or intermittent connection	3
Device damaged prior to use	3
Failure of device to self-test	3
Material deformation	3
Output energy incorrect	3
Failure to Adhere or Bond	3
Total Device Problems	4268

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	7	10	8	15	15	21	5
Class III	0	0	1	0	0	1	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap, Inc.	II	Feb-26-2013
2	Angiodynamics, INC	II	Aug-24-2011
3	ArthroCare Corporation	II	Aug-30-2009
4	ArthroCare Corporation	II	Sep-19-2008
5	Barrx Medical, Inc.	II	Jul-06-2011
6	Barrx Medical, Inc.	II	Oct-31-2008
7	Boston Scientific Corp	II	Sep-09-2009
8	Boston Scientific Corp	II	Sep-16-2008
9	Boston Scientific Corp	II	Sep-11-2008
10	Boston Scientific Corporation	II	Oct-18-2012
11	Boston Scientific Corporation	III	Mar-28-2012
12	Cambridge Endoscopic Devices, Incorporated	II	Jul-06-2011
13	Centurion Medical Products	II	May-12-2010
14	ConMed Corporation	II	Feb-15-2013
15	ConMed Corporation	II	Jan-24-2013
16	ConMed Electrosurgery	II	May-29-2012
17	ConMed Electrosurgery	II	May-29-2012
18	ConMed Electrosurgery	II	Feb-17-2011
19	ConMed Electrosurgery	II	Aug-25-2010
20	ConMed Electrosurgery	II	May-10-2010
21	ConMed Electrosurgery	II	Nov-10-2009
22	ConMed Electrosurgery	II	Dec-11-2007
23	ConvaTec	II	Mar-16-2010
24	Covidien LLC	II	Sep-14-2012
25	Covidien LP	II	Jan-25-2011
26	Covidien, PLC	II	Jan-11-2012
27	Covidien, PLC	II	Aug-30-2011
28	Datascope Corporation	II	Aug-09-2007
29	DePuy Mitek, Inc., a Johnson & Johnson Co.	II	Oct-24-2012
30	DePuy Mitek, Inc., a Johnson & Johnson Co.	II	Aug-27-2010
31	Ellman International, Inc.	II	May-17-2012
32	Encision, Inc.	II	Jul-06-2012
33	Encision, Inc.	II	Aug-30-2011
34	Encision, Inc.	II	May-31-2011
35	Encision, Inc.	II	May-06-2010
36	Ethicon Endo-Surgery Inc	II	Jan-31-2013
37	Ethicon Endo-Surgery Inc	II	Mar-21-2012
38	Ethicon Endo-Surgery Inc	II	Feb-15-2011
39	Gyrus ACMI Corporation	II	Jan-14-2010
40	Gyrus ACMI Corporation	II	Nov-05-2008
41	Gyrus Acmi, Incorporated	II	Sep-30-2010
42	Hemostatix Medical Technologies LLC	II	Sep-28-2010
43	Innovatech Medical Resources L.P.	II	Jan-11-2012
44	Kentucky Packaging Service LP	II	Nov-10-2009
45	Linvatec Corp. dba ConMed Linvatec	II	Sep-09-2009
46	Maquet Cardiovascular, LLC	II	Sep-20-2011
47	Medtronic Cardiac Surgery Technologies	II	Feb-02-2008
48	Medtronic Neuromodulation	II	Apr-02-2013
49	Megadyne Medical Products, Inc.	III	Dec-03-2009
50	Microline Surgical, Inc.	II	Aug-29-2011
51	Nellcor Puritan Bennett Inc. (dba Covidien LP)	II	Aug-29-2012
52	Olympus America Inc.	II	Jan-13-2012
53	PSC Industries Inc	II	Jul-12-2012
54	PSC Industries Inc	II	Jul-11-2012
55	Peak Surgical	II	Feb-02-2011
56	Plasma Surgical Inc.	II	Jun-11-2012
57	Rhytec Inc.	II	Feb-01-2007
58	Rita Medical Systems, Inc.	II	Apr-19-2007
59	Smith & Nephew, Inc. Endoscopy Division	II	Aug-03-2012
60	Smith & Nephew, Inc. Endoscopy Division	II	Jan-11-2012
61	Sorin Group USA, Inc.	II	Jan-14-2010
62	Sound Surgical Technologies, LLC	II	Jan-25-2011
63	Sound Surgical Technologies, LLC	II	Mar-13-2008
64	Starion Instruments	II	Aug-19-2010
65	Starion Instruments	II	Jul-09-2010
66	Starion Instruments	II	Jul-08-2010
67	Sterilmed Inc	II	Jan-13-2009
68	Stingray Surgical Products, LLC	II	Jul-13-2012
69	Stryker Endoscopy	II	Jul-09-2012
70	Stryker Endoscopy	II	Nov-21-2011
71	Stryker Endoscopy	II	Mar-17-2011
72	Stryker Endoscopy	II	Aug-09-2010
73	Stryker Endoscopy	II	Feb-09-2009
74	Stryker Endoscopy	II	Mar-05-2008
75	Stryker Endoscopy	II	Jan-17-2008
76	Stryker Sustainability Solutions, Inc.	II	Mar-13-2012
77	Telefelx Medical	II	Sep-27-2010
78	Unimed Surgical Products, Inc.	II	Aug-28-2012
79	Unimed Surgical Products, Inc.	II	Oct-21-2009
80	VNUS Medical Technologies Inc	II	Jan-24-2008
81	VNUS Medical Technologies Inc	II	Dec-15-2007
82	Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK	II	Nov-07-2007
83	Zinnanti Surgical Design LLC	II	Aug-14-2007