ClearanceBrief
Panels › General, Plastic Surgery › Product code GEI · Class 2

Electrosurgical, Cutting & Coagulation & Accessories

Regulation 878.4400

47510(k)s in 12 months (2,321 all time)
18recalls in 12 months (644 all time)
601recalls that name a 510(k)
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Top companies in GEI

Company510(k)sRecalls
ArthroCare Corporation865
Conmed Corporation2553
Valleylab690
Megadyne Medical Products, Inc.3231
Covidien4114
Carefusion 2200, Inc.245
Stryker935
Conmedcorp430
Gyrus Acmi, Inc.2120
Bovie Medical2115
DateFirm and productCodeLinked 510(k)
Jul 13, 2006Smith & Nephew, Inc. Endoscopy Division
Dyonics Electroblade 4.5 ELITE, Full Radius, Valleylab Generator- Compatible Part Number: 7209700
Terminated		 GEIK031675
Jul 13, 2006Smith & Nephew, Inc. Endoscopy Division
Dyonics Electroblade, 4.5 Full Radius, Valleylab Generator-Compatible Part Number: 7205961
Terminated		 GEIK031675
Jul 13, 2006Smith & Nephew, Inc. Endoscopy Division
5.5 mm TRIVEX System Resector Kit (blade and tubing), 3 per box Part Number: 7209515
Terminated		 GEIK990723
Jul 13, 2006Smith & Nephew, Inc. Endoscopy Division
4.5 mm TRIVEX System Resector Kit (blade and tubing), 3 per box Part Number: 7209514
Terminated		 GEIK990723
Jul 13, 2006Smith & Nephew, Inc. Endoscopy Division
TriVex 200LV Resector Kit, 5.5 Part Number: 7209271
Terminated		 GEIK990723
Jul 13, 2006Smith & Nephew, Inc. Endoscopy Division
TriVex 100SV Resector Kit, 4.5 Part Number: 7205876
Terminated		 GEIK990723
Jun 27, 2006Gyrus Medical, Inc.
GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.93 or greater or
Terminated		 GEIK020585
May 31, 2006Rita Medical Systems, Inc.
XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. * StarBurst Xli enhanced with tubing set * * REF/Catalog: 700-103027 * 4-7 cm Diameter * 12cm Length * Sterile/R * RITA *
Terminated		 GEIK010060
May 31, 2006Rita Medical Systems, Inc.
Talon Straight, 25 cm--Electrosurgical Device--RITA * Medical Systems, Inc. * StarBurst Talon * * REF: 700-102846 * 4 cm Diameter * 25 cm Length * Sterile/R * Catalog # 700-102846-RITA * Manufactured
Terminated		 GEIK010060
May 10, 2006Covidien LP
Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue.
Terminated		 GEIK984552
Apr 19, 2006Megadyne Medical Products, Inc
Button Switch Electrosurgical Pencil with Holster
Terminated		 GEIK965054
Apr 19, 2006Megadyne Medical Products, Inc
Rocker Switch Electrosurgical Pencil with Holster
Terminated		 GEIK965054
Apr 19, 2006Megadyne Medical Products, Inc
Button Switch Electrosurgical Pencil with Stainless Steel Tip and Holster
Terminated		 GEIK965054
Apr 19, 2006Megadyne Medical Products, Inc
Rocker Switch Electrosurgical Pencil with Stainless Steel Tip and Holster
Terminated		 GEIK965054
Apr 19, 2006Megadyne Medical Products, Inc
Button Switch Electrosurgical Pencil with Modified E-Z Clean Tip and Holster
Terminated		 GEIK965054
Apr 19, 2006Megadyne Medical Products, Inc
Rocker Switch Electrosurgical Pencil with Modified E-Z Clean Tip and Holster
Terminated		 GEIK965054
Apr 19, 2006Megadyne Medical Products, Inc
Button Switch Electrosurgical Pencil with E-Z Clean Tip and Holster
Terminated		 GEIK965054
Apr 19, 2006Megadyne Medical Products, Inc
Rocker Switch Electrosurgical Pencil with E-Z Clean Tip
Terminated		 GEIK965054
Apr 19, 2006Covidien LP
LigaSure Atlas 20 cm Open Procedure Vessel Sealer/Divider
Terminated		 GEIK010013
Apr 19, 2006Covidien LP
LigaSure Atlas Laparoscopic Vessel Sealer/Divider
Terminated		 GEIK010013
Apr 11, 2006Rubicor Medical
Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and distributed by Rubicor Medical, Inc., 600 Chesapeake Dr., Redwood City, CA 94063
Terminated		 GEIK020047
K023601 +3
Oct 7, 2005Rita Medical Systems
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Terminated		 GEIK051420
Sep 14, 2005Boston Scientific Corp
Boston Scientific brand LeVeen Needle Electrode, 5.0/13/25; Model number M001262170,Ref 26-217.
Terminated		 GEIK982556
Sep 14, 2005Boston Scientific Corp
Boston Scientific brand LeVeen Needle Electrode, 5.0/13/15; Model number M001262160, Ref 26-216.
Terminated		 GEIK982556
Aug 31, 2005Boston Scientific Corp
Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model M001262400, catalog number 26-240.
Terminated		 GEINone listed
Feb 25, 2005TissueLink Medical, Inc.
Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1
Terminated		 GEIK014260
Sep 22, 2004Encision, Inc.
AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.
Terminated		 GEIK912780
Sep 1, 2004TissueLink Medical, Inc.
ADP 3.2 Adapter, non sterile reusable Model Number: 30-801-1, an accessory used with the TissueLink Bipolar Floating Device
Terminated		 GEIK020574
K022532
Sep 1, 2004TissueLink Medical, Inc.
ADP2.1 Adapter, non-sterile reusable Model Number: 30-802-1 ,an accessory used with the TissueLink BiPolar Floating Device
Terminated		 GEIK020574
K022532
Aug 28, 2004Conmed Corporation
ConMed Stealth Coated Laparoscopic Electrodes with 4mm pin (60-5158 series) as follows: Cat. #60-5158-034 - Spatula, 5 mm x 32 cm; Cat #60-5158-432 - ''L'' Hook 5 mm x 32 cm; Cat #60-5158-934 - Needl
Terminated		 GEIK960808
Aug 28, 2004Conmed Corporation
ConMed Stealth Coated Laparoscopic Electrodes with 3/32'' pin (60-5158 series) as follows: Cat. #60-5158-027 - Spatula 5 mm x 27 cm; Cat #60-5158-032 - Spatula 5 mm x 32 cm; Cat. #60-5158-044 - Spatu
Terminated		 GEIK960808
Aug 28, 2004Biomet, Inc.
Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No. 450026.
Terminated		 GEIK945765
Jul 31, 2004Conmed Corporation
ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat. #60-5158-034 - Spatula; Cat. #60-5158-234 -''J'' Hook; Cat. #60-5158-432 - ''L'' Hook; Cat. # 60-5158-934 - Needle.
Terminated		 GEIK960808
Jul 22, 2004Encision, Inc.
Encision ES4107 Disposable AEM Cord, Sterile.
Terminated		 GEIK913625
Jul 20, 2004Gyrus Medical, Inc
Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications.
Terminated		 GEINone listed
Nov 19, 2003ConMed Electrosurgery
Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may equal -100, -115, -220 and -230.
Terminated		 GEIK970493
Nov 1, 2003Rita Medical Systems
RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649
Terminated		 GEIK031926
Jul 24, 2003Encision, Inc.
EM2M NC AEM Monitor, (NON-COM)
Terminated		 GEIK000480
Jul 24, 2003Encision, Inc.
EM2+A NC AEM Monotor (NON-COM)
Terminated		 GEIK000480
Jul 24, 2003Encision, Inc.
EM2 NC AEM Monitor (NON-COM)
Terminated		 GEIK000480
Feb 13, 2003Thermage
ThermaCool TC 1.0 cm2 Treatment Tip, Single Patient Use Only
Terminated		 GEINone listed
Jan 30, 2003Encision, Inc.
AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B
Terminated		 GEIK912780
Jan 30, 2003Megadyne Medical Products, Inc
Megadyne MegaTip, Modified E-Z Clean Non Stick Cautery Tip, CAT/REF 0600M, Single Use Only, STERILE
Terminated		 GEIK943055
Jan 30, 2003Megadyne Medical Products, Inc
Megadyne MegaTip, E-Z Clean Non Stick Cautery Tip, CAT/REF 0600, Single Use Only, STERILE
Terminated		 GEIK943055

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