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

DateFirm and productCodeLinked 510(k)
Sep 9, 2009Boston Scientific Corp
Boston Scientific, LeVeen Needle Electrode, 25 cm, 5.0 cm, sterile; REF M001262170. For tissue coagulation.
Terminated
GEIK000032
Sep 9, 2009Boston Scientific Corp
Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation.
Terminated
GEIK000032
Aug 30, 2009ArthroCare Corporation
ArthroWand Saber 30 with Integrated Cable wand, Catalog number AC4330-01, Manufactured by ArthroCare Corporation, Sunnyvale, CA
Terminated
GEIK030551
Feb 9, 2009Stryker Endoscopy
Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; Model Number: 279-351-300; Manufactured By: Stryker Endoscopy, Puerto Rico
Terminated
GEIK041810
Jan 13, 2009Sterilmed Inc
RF Arthroscopy Probe Model #'s: ARTA1325-01 ARTA1335-01 ARTA1345-01 ARTA1730-01 ARTA2630-01 ARTA3625-01 ARTA4330-01 ARTAS1335-01 ARTAS4630-01 ARTASC1335-01 ARTASC2530-01 ARTASC4250-01 ARTASC4830-01
Terminated
GEIK012679
Nov 5, 2008Gyrus ACMI Corporation
Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use only bipolar electrosurgical instrument with the ability to cut and coagulate soft tissue in head and neck surgery with
Terminated
GEIK041285
Oct 31, 2008Barrx Medical, Inc.
Hydrophobic HALO360 Filter that is packaged with HALO360+ Ablation Catheters Model numbers 32041-22, 32041-28, 32041-31 and 32041-34, and/or with HALO360 Sizing Balloon Model number 3441B.
Terminated
GEINone listed
Sep 19, 2008ArthroCare Corporation
ArthroCare ArthroWand Covator with Integrated Cable Wand, Catalog number AC4340-01. The product is a medical device for human use in electrosurgical cutting and coagulation accessories. Product is i
Terminated
GEIK033584
Sep 16, 2008Boston Scientific Corp
Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile. The device is intended to be used in conjunction with a Radio Therapeutics Corporation radiofrequency (RF) generator for th
Terminated
GEIK982556
Sep 16, 2008Boston Scientific Corp
Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/15 cm, sterile. The device is intended to be used in conjunction with a Radio Therapeutics Corporation radiofrequency (RF) generator for th
Terminated
GEIK982556
Sep 16, 2008Boston Scientific Corp
Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile. The device is intended to be used in conjunction with a Radio Therapeutics Corporation radiofrequency (RF) generator for th
Terminated
GEIK982556
Sep 16, 2008Boston Scientific Corp
Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile. The device is intended to be used in conjunction with a Radio Therapeutics Corporation radiofrequency (RF) generator for th
Terminated
GEIK982556
Sep 11, 2008Boston Scientific Corp
Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile, Boston Scientific, Spencer, IN; REF 26-229, UPN M001262290. The product is used with radiofrequency generator for the therm
Terminated
GEIK982556
Sep 11, 2008Boston Scientific Corp
Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/15 cm, sterile, Boston Scientific, Spencer, IN; REF 26-228, UPN M001262280. The product is used with radiofrequency generator for the therm
Terminated
GEIK982556
Sep 11, 2008Boston Scientific Corp
Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile, Boston Scientific, Spencer, IN; REF 26-227, UPN M001262270. The product is used with radiofrequency generator for the therm
Terminated
GEIK982556
Sep 11, 2008Boston Scientific Corp
Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile, Boston Scientific, Spencer, IN; REF 26-226, UPN M001262260. The product is used with a radiofrequency generator for the the
Terminated
GEIK982556
Mar 13, 2008Sound Surgical Technologies, LLC
Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214-005112232. Sound Surgical Technologies, LLC, Louisville, CO 80027.
Terminated
GEIK022051
K053510 +2
Mar 5, 2008Stryker Endoscopy
Stryker Disposable StrykeProbe 32cm Spatula Tip, Ref: 250-070-551, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138.
Terminated
GEIK052141
Mar 5, 2008Stryker Endoscopy
Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138.
Terminated
GEIK052141
Feb 2, 2008Medtronic Cardiac Surgery Technologies
Medtronic Cardioblate Gemini-s, model 49260. Surgical Ablation Device. Sterilized using Ethylene Oxide. Two, unique jaw curvatures are provided: a standard curve (model 49260) and extra curve (Mod
Terminated
GEINone listed
Jan 24, 2008VNUS Medical Technologies Inc
VNUS 7F ClosureFAST Catheter, Order # ClF7-7-100 (100 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138
Terminated
GEINone listed
Jan 24, 2008VNUS Medical Technologies Inc
VNUS 7F ClosureFAST Catheter, Order #: CF7-7-60 (60 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138
Terminated
GEIK061373
Jan 17, 2008Stryker Endoscopy
SERFAS Energy Suction Probe, Model 279-351-100, 3.5mm 90-S, Manufactured by Stryker Puerto Rico
Terminated
GEIK041810
Dec 15, 2007VNUS Medical Technologies Inc
VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138
Terminated
GEIK061373
Dec 11, 2007ConMed Electrosurgery
Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers : 138100 through 138-105, 138107, 138110, 138112 and 138113, and Ultra Clean Accessory Electrode, Part/REF Numbers: 139100, 139107
Terminated
GEIK935091
K991855
Nov 7, 2007Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw, Indiana; REF (P/N) 9560575.
Terminated
GEIK930511
Aug 14, 2007Zinnanti Surgical Design LLC
Bayonet Electrosurgical Pencil. P/N 9560575. The product is shipped in cases containing 100 blades/pencils.
Terminated
GEIK930511
Aug 9, 2007Datascope Corporation
Precision Bipolar Device 6 pack Consists of a six-pack of the Precision Bipolar Device. Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004-0011
Terminated
GEIK003587
Aug 9, 2007Datascope Corporation
The ClearGlide EVH small with Scissors. The kit includes three Precision Bipolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor, a Vessel Dissector, and the ENDOPATH 5mm curved scissors
Terminated
GEIK003587
Aug 9, 2007Datascope Corporation
Precision Bipolar Device ClearGlide EVH Small (endoscopic vessel harvesting system) The kit included three Precision BiPolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor and a Vessel
Terminated
GEIK003587
Apr 19, 2007Rita Medical Systems, Inc.
RITA Starburst MRI SemiFlex (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816
Terminated
GEIK992693
Apr 19, 2007Rita Medical Systems, Inc.
RITA StarBurst (2-3cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816
Terminated
GEIK983871
Apr 19, 2007Rita Medical Systems, Inc.
RITA Starburst XL (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816
Terminated
GEIK992693
Feb 1, 2007Rhytec Inc.
Portrait PSR3 System, an electro-surgical device used in dermatological applications
Terminated
GEIK060948
Oct 27, 2006Conmed Corporation
ConMed DetachaTip Laparoscopic Instrument: Meeker (Right Angle) Multiple Use Grasper, 5mm x 43cm length, REF/Product Code 1-4317. --- The product is distributed sterile in heat-sealed tray and labeled
Terminated
GEIK924283
Oct 27, 2006Conmed Corporation
ConMed DetachaTip Laparoscopic Instrument: Meeker (Right Angle) Multiple Use Grasper, 5mm x 33cm length, REF/Product Code 1-1017. --- The product is distributed sterile in heat-sealed tray and labeled
Terminated
GEIK924283
Oct 27, 2006Conmed Corporation
ConMed DetachaTip Laparoscopic Instrument: Fenestrated (Duckbill) Multiple Use Grasper, 5mm x 43cm, REF/Product Code 1-4307. --- The product is distributed sterile in heat-sealed tray and labeled with
Terminated
GEIK924283
Oct 27, 2006Conmed Corporation
ConMed DetachaTip Laparoscopic Instrument: Endoweave Multiple Use Grasper, 5mm x 43cm length, REF/Product Code 1-4328. --- The product is distributed sterile in heat-sealed tray and labeled with an ex
Terminated
GEIK924283
Oct 27, 2006Conmed Corporation
ConMed DetachaTip Laparoscopic Instrument: Curved ''Maryland'' Multiple Use Grasper, 5mm x 43cm length, REF/Product Code 1-4308. --- The product is distributed sterile in heat-sealed tray and labeled
Terminated
GEIK924283
Oct 27, 2006Conmed Corporation
ConMed DetachaTip Laparoscopic Instrument: Curved ''Maryland'' Multiple Use Grasper, 5mm x 33cm length, REF/Product Code 1-1009. --- The product is distributed sterile in heat-sealed tray and labeled
Terminated
GEIK924283
Oct 27, 2006Conmed Corporation
ConMed DetachaTip Laparoscopic Instrument: Babcock Multiple Use Grasper, 5mm x 43cm length, REF/Product Code 1-4305. --- The product is distributed sterile in heat-sealed tray and labeled with an expi
Terminated
GEIK924283
Oct 27, 2006Conmed Corporation
ConMed DetachaTip Laparoscopic Instrument: Babcock Multiple Use Grasper, 5mm x 33cm length, REF/Product Code 1-1005. --- The product is distributed sterile in heat-sealed tray and labeled with an expi
Terminated
GEIK924283
Oct 27, 2006Conmed Corporation
ConMed DetachaTip Laparoscopic Instrument: Allis Multiple Use Grasper, 5mm x 43cm length, REF/Product Code 1-4319. --- The product is distributed sterile in heat-sealed tray and labeled with an expira
Terminated
GEIK924283
Oct 27, 2006Conmed Corporation
ConMed DetachaTip Laparoscopic Instrument: Allis Multiple Use Grasper, 5mm x 33cm length, REF/Product Code 1-1019. --- The product is distributed sterile in heat-sealed tray and labeled with an expira
Terminated
GEIK924283
Sep 19, 2006Conmed Electrosurgery
Conmed System 5000 Electrosurgical unit, REF 60-8005-SYS, 60-8015-SYS, 60-8018-SYS, 60-8005-001, 60-8005-003, Conmed Corporation.
Terminated
GEIK020186
Sep 19, 2006Conmed Electrosurgery
Conmed System 2500 Electrosurgical Unit, REF 60-8011-SYS, Conmed Corporation
Terminated
GEIK020135
Aug 24, 2006Conmed Corporation
ConMed DetachaTip Multi-Use Laparoscopic Instrument, "Endoweave Multiple Use Grasper", 5 mm x 33 cm, REF/Product code 1-1028. -------- The product is distributed sterile in heat-sealed tray and labele
Terminated
GEIK924283
Aug 24, 2006Conmed Corporation
ConMed DetachaTip Multi-Use Laparoscopic Instrument - "Fenestrated (Duckbill) Multiple Use Grasper", 5 mm x 33 cm, REF/Product code-1-1008. ------- The product is distributed sterile in heat-sealed
Terminated
GEIK924283
Jul 13, 2006Smith & Nephew, Inc. Endoscopy Division
Dyonics Electroblade 4.5 ELITE, Full Radius, VULCAN Generator-Compatible Part Number: 7209983
Terminated
GEIK031675
Jul 13, 2006Smith & Nephew, Inc. Endoscopy Division
Dyonics Electroblade 4.5 Full Radius, VULCAN Generator-Compatible Product number: 7209855
Terminated
GEIK031675

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