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)
Top companies in GEI
| Company | 510(k)s | Recalls |
|---|---|---|
| ArthroCare Corporation | 86 | 5 |
| Conmed Corporation | 25 | 53 |
| Valleylab | 69 | 0 |
| Megadyne Medical Products, Inc. | 32 | 31 |
| Covidien | 41 | 14 |
| Carefusion 2200, Inc. | 2 | 45 |
| Stryker | 9 | 35 |
| Conmedcorp | 43 | 0 |
| Gyrus Acmi, Inc. | 21 | 20 |
| Bovie Medical | 21 | 15 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2009 | Boston Scientific Corp Boston Scientific, LeVeen Needle Electrode, 25 cm, 5.0 cm, sterile; REF M001262170. For tissue coagulation. Terminated |
GEI | K000032 |
| Sep 9, 2009 | Boston Scientific Corp Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation. Terminated |
GEI | K000032 |
| Aug 30, 2009 | ArthroCare Corporation ArthroWand Saber 30 with Integrated Cable wand, Catalog number AC4330-01, Manufactured by ArthroCare Corporation, Sunnyvale, CA Terminated |
GEI | K030551 |
| Feb 9, 2009 | Stryker 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 |
GEI | K041810 |
| Jan 13, 2009 | Sterilmed 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 |
GEI | K012679 |
| Nov 5, 2008 | Gyrus 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 |
GEI | K041285 |
| Oct 31, 2008 | Barrx 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 |
GEI | None listed |
| Sep 19, 2008 | ArthroCare 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 |
GEI | K033584 |
| Sep 16, 2008 | Boston 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 |
GEI | K982556 |
| Sep 16, 2008 | Boston 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 |
GEI | K982556 |
| Sep 16, 2008 | Boston 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 |
GEI | K982556 |
| Sep 16, 2008 | Boston 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 |
GEI | K982556 |
| Sep 11, 2008 | Boston 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 |
GEI | K982556 |
| Sep 11, 2008 | Boston 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 |
GEI | K982556 |
| Sep 11, 2008 | Boston 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 |
GEI | K982556 |
| Sep 11, 2008 | Boston 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 |
GEI | K982556 |
| Mar 13, 2008 | Sound Surgical Technologies, LLC Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214-005112232. Sound Surgical Technologies, LLC, Louisville, CO 80027. Terminated |
GEI | K022051 K053510 +2 |
| Mar 5, 2008 | Stryker Endoscopy Stryker Disposable StrykeProbe 32cm Spatula Tip, Ref: 250-070-551, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138. Terminated |
GEI | K052141 |
| Mar 5, 2008 | Stryker Endoscopy Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138. Terminated |
GEI | K052141 |
| Feb 2, 2008 | Medtronic 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 |
GEI | None listed |
| Jan 24, 2008 | VNUS 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 |
GEI | None listed |
| Jan 24, 2008 | VNUS 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 |
GEI | K061373 |
| Jan 17, 2008 | Stryker Endoscopy SERFAS Energy Suction Probe, Model 279-351-100, 3.5mm 90-S, Manufactured by Stryker Puerto Rico Terminated |
GEI | K041810 |
| Dec 15, 2007 | VNUS Medical Technologies Inc VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138 Terminated |
GEI | K061373 |
| Dec 11, 2007 | ConMed 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 |
GEI | K935091 K991855 |
| Nov 7, 2007 | Warsaw 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 |
GEI | K930511 |
| Aug 14, 2007 | Zinnanti Surgical Design LLC Bayonet Electrosurgical Pencil. P/N 9560575. The product is shipped in cases containing 100 blades/pencils. Terminated |
GEI | K930511 |
| Aug 9, 2007 | Datascope 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 |
GEI | K003587 |
| Aug 9, 2007 | Datascope 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 |
GEI | K003587 |
| Aug 9, 2007 | Datascope 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 |
GEI | K003587 |
| Apr 19, 2007 | Rita 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 |
GEI | K992693 |
| Apr 19, 2007 | Rita 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 |
GEI | K983871 |
| Apr 19, 2007 | Rita 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 |
GEI | K992693 |
| Feb 1, 2007 | Rhytec Inc. Portrait PSR3 System, an electro-surgical device used in dermatological applications Terminated |
GEI | K060948 |
| Oct 27, 2006 | Conmed 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 |
GEI | K924283 |
| Oct 27, 2006 | Conmed 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 |
GEI | K924283 |
| Oct 27, 2006 | Conmed 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 |
GEI | K924283 |
| Oct 27, 2006 | Conmed 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 |
GEI | K924283 |
| Oct 27, 2006 | Conmed 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 |
GEI | K924283 |
| Oct 27, 2006 | Conmed 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 |
GEI | K924283 |
| Oct 27, 2006 | Conmed 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 |
GEI | K924283 |
| Oct 27, 2006 | Conmed 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 |
GEI | K924283 |
| Oct 27, 2006 | Conmed 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 |
GEI | K924283 |
| Oct 27, 2006 | Conmed 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 |
GEI | K924283 |
| Sep 19, 2006 | Conmed 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 |
GEI | K020186 |
| Sep 19, 2006 | Conmed Electrosurgery Conmed System 2500 Electrosurgical Unit, REF 60-8011-SYS, Conmed Corporation Terminated |
GEI | K020135 |
| Aug 24, 2006 | Conmed 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 |
GEI | K924283 |
| Aug 24, 2006 | Conmed 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 |
GEI | K924283 |
| Jul 13, 2006 | Smith & Nephew, Inc. Endoscopy Division Dyonics Electroblade 4.5 ELITE, Full Radius, VULCAN Generator-Compatible
Part Number: 7209983 Terminated |
GEI | K031675 |
| Jul 13, 2006 | Smith & Nephew, Inc. Endoscopy Division Dyonics Electroblade 4.5 Full Radius, VULCAN Generator-Compatible
Product number: 7209855 Terminated |
GEI | K031675 |
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