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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 7, 2012 | K113407 | SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS Carefusion 2200, Inc. | GEI |
| Sep 5, 2012 | K113572 | LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER Covidien, Formerly Valleylab, A Division of Tyco H | GEI |
| Aug 23, 2012 | K122086 | THERMAL LIGATING SHEARS Microline Surgical, Inc. | GEI |
| Jul 10, 2012 | K121426 | AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS Synergetics, Inc. | GEI |
| Jun 29, 2012 | K120581 | SC TIP CLEANER Nsi | GEI |
| Jun 25, 2012 | K121290 | AQUAMANTRYS3 BSC 9.1S Medtronic, Inc. | GEI |
| Jun 18, 2012 | K120527 | ALPHA ORTHOPAEDICS AT2 SYSTEM Alpha Orthopaedics, Inc. | GEI |
| Jun 12, 2012 | K120476 | MACROLYTE DISPERSIVE ELECTRODE Conmed Corporation | GEI |
| Jun 12, 2012 | K120322 | CONMED SUREFIT DUAL DISPERSIVE ELECTRODE Conmed Corporation | GEI |
| Jun 3, 2012 | K113597 | MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES Minilap Technologies | GEI |
| May 23, 2012 | K111262 | ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP Olsen Medical | GEI |
| May 10, 2012 | K120537 | AQUAMANTYS3 9.5 XL BIPOLAR SEALER Medtronic, Inc. | GEI |
| May 3, 2012 | K120431 | HALO90 ULTRA ABLATION CATHETER Barrx Medical, Inc. | GEI |
| Apr 6, 2012 | K120095 | SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND Depuy Mitek, A Johnson & Johnson Company | GEI |
| Mar 27, 2012 | K120416 | INSULATION TESTER Spectrum Surgical Supply Corp. | GEI |
| Mar 22, 2012 | K113265 | GENII GI 4000 ELECTROSUGICAL GENERATOR Genii, Inc. | GEI |
| Mar 15, 2012 | K113090 | LEVEEN SUPERSLIM NEEDLE ELECTRODE Boston Scientific Corporation | GEI |
| Mar 13, 2012 | K111523 | OSTEOCOOL (TM) RF ABLATION SYSTEM Baylis Medical Co., Inc., CA | GEI |
| Mar 2, 2012 | K111670 | VENUS FREEZE (MP)2 SYSTEM Venus Concept , Ltd., IL | GEI |
| Feb 27, 2012 | K113545 | VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN Depuy Mitek, A Johnson & Johnson Company | GEI |
| Jan 27, 2012 | K112233 | BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE Bovie Medical Corporation | GEI |
| Jan 26, 2012 | K111986 | LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM Surgical Innovations Plc, GB | GEI |
| Jan 20, 2012 | K111202 | SURGICAL TISSUE MANAGEMENT SYSTEM Olympus Medical Systems Corp. | GEI |
| Jan 5, 2012 | K112454 | HALO60 ABLATION CATHETER Barrx Medical, Inc. | GEI |
| Dec 20, 2011 | K103508 | UNMIAX LAPAROSCOPIC INSTRUMENT Unimax Medical Systems, Inc., TW | GEI |
| Dec 20, 2011 | K102921 | ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES Bema-GmbH & Co. KG, NL | GEI |
| Dec 9, 2011 | K113500 | CANADY VIEIRA HYBRID PLASMA SCALPEL Us Medical Innovations, LLC | GEI |
| Dec 7, 2011 | K110924 | DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS Synergetics, Inc. | GEI |
| Dec 5, 2011 | K111732 | AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER Salient Surgical Technologies, Inc. | GEI |
| Nov 16, 2011 | K111026 | APOLLO Pollogen, Ltd., IL | GEI |
| Nov 9, 2011 | K102752 | STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS Stingray Surgical Products, Inc. | GEI |
| Nov 8, 2011 | K112033 | ENSEAL G2 TISSUS SEALERS Ethicon Endo-Sugery, LLC | GEI |
| Oct 7, 2011 | K111784 | VENUS SWAN SYSTEM Venus Concept , Ltd., IL | GEI |
| Oct 3, 2011 | K110672 | ETWO SKIN TREATMENT SYSTEM Syneron, Ltd., IL | GEI |
| Sep 30, 2011 | K111412 | SURGISTEER SCISSORS, SURGISTEER DISSECTOR / GRASPER, SURGISTEER HOOK Steerable Technologix | GEI |
| Sep 26, 2011 | K110462 | KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE Kepler Medtec | GEI |
| Sep 9, 2011 | K111887 | CLOSUREFAST RADIOFREQUENCY CATHETER Covidien | GEI |
| Sep 9, 2011 | K111285 | AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING Salient Surgical Technologies, Inc. | GEI |
| Jul 18, 2011 | K110439 | DOMAIN SURGICAL SYSTEM Domain Surgical, Inc. | GEI |
| Jul 11, 2011 | K110824 | ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT Aragon Surgical, Inc. | GEI |
| Jun 29, 2011 | K111672 | MAX ORIENT SUCTION DEVICE FOR ELECTROCAUTERIZER Pacific Hospital Supply Co., Ltd., TW | GEI |
| Jun 28, 2011 | K110695 | BIPOLAR HF DEVICE Aesculap, Inc. | GEI |
| Jun 13, 2011 | K101990 | ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11 Ethicon Endo-Sugery, LLC | GEI |
| Jun 2, 2011 | K110143 | HET BIPOLAR ELECTROCAUTERY FORCEPS Het Systems, LLC | GEI |
| Jun 2, 2011 | K102461 | FRACTORA Invasix , Ltd., IL | GEI |
| May 31, 2011 | K110268 | FORCETRIAD ELECTROSURGICAL GENERATOR Covidien Lp, Formerly Know AS Valleylab, A Divison | GEI |
| May 27, 2011 | K103775 | PEAK SUCTION COAGULATOR Peak Surgical, Inc. | GEI |
| May 6, 2011 | K102913 | FORCETRIAD Covidien, Formerly Valleylab, A Division of Tyco H | GEI |
| Apr 6, 2011 | K100669 | CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES Us Medical Innovations, LLC | GEI |
| Apr 5, 2011 | K101057 | AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1 Salient Surgical Technologies | GEI |
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