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 |
|---|---|---|---|
| Oct 7, 2013 | K133017 | ESTECH COBRA(R) GENESIS BIPOLAR CLAMP Estech, Inc. | GEI |
| Oct 3, 2013 | K132199 | DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST Deroyal Industries, Inc. | GEI |
| Oct 3, 2013 | K131435 | ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, Ethicon Endo-Surgery, LLC | GEI |
| Sep 26, 2013 | K130983 | GENII ARC SMART ARGON PROBE Genii, Inc. | GEI |
| Sep 25, 2013 | K132665 | PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC Ellman International, Inc. | GEI |
| Sep 16, 2013 | K130760 | ELECTROSURGICAL GENERATOR Beijing Jinhengwei Technology Development Co., Ltd., CN | GEI |
| Sep 6, 2013 | K132431 | THERMAGE CPT SYSTEM Solta Medical, Inc. | GEI |
| Sep 6, 2013 | K132136 | SINGLE USE GROUNDING PAD Lccs Products Limited, CN | GEI |
| Aug 30, 2013 | K132374 | BAYLIS MEDICAL RF PERFORATION PROBE V2.0 Baylis Medical Company, Inc., CA | GEI |
| Aug 26, 2013 | K131949 | AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES Encision, Inc. | GEI |
| Aug 23, 2013 | K131012 | SUTTER BIPOLAR FORCEPS - SUPERGLISS Sutter Medizintechnik GmbH, DE | GEI |
| Aug 22, 2013 | K132099 | ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND ArthroCare Corporation | GEI |
| Aug 22, 2013 | K130027 | DISPOSABLE NEUTRAL ELECTRODE GP202 Cathay Manufacturing Corp., CN | GEI |
| Aug 16, 2013 | K130793 | NEWA SKIN THERAPY SYSTEM Endymion Medical, Ltd., IL | GEI |
| Aug 13, 2013 | K123061 | ACE MONOPOLAR ATTACHMENT Bioeconeer, Inc., TW | GEI |
| Aug 9, 2013 | K131205 | ARTHROCARE HEAD AND NECK COBLATION WAND ArthroCare Corporation | GEI |
| Jul 19, 2013 | K120510 | TRANSCEND Syneron Medical, Ltd., IL | GEI |
| Jul 12, 2013 | K123366 | SURGITRON 4.0 DUAL RF S5-IEC Ellman International, Inc. | GEI |
| Jul 2, 2013 | K122652 | ARTHROCARE TURBINATOR WAND ArthroCare Corporation | GEI |
| Jun 25, 2013 | K121481 | INFINI RADIOFREQUENCY SYSTEM Lutronic Corporation | GEI |
| May 22, 2013 | K123662 | THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM Justright Surgical, LLC | GEI |
| May 10, 2013 | K123478 | STINGRAY BIPOLAR FORCEPS Stingray Surgical Products | GEI |
| Apr 18, 2013 | K122200 | A3F FRATIONAL Pollogen, Ltd., IL | GEI |
| Apr 17, 2013 | K122716 | PLASMATRODE SALINE SAFE TUR ELECTRODE Cook Ireland, Ltd., IE | GEI |
| Apr 8, 2013 | K122966 | XP200 Btl Industries, Ltd. | GEI |
| Apr 5, 2013 | K130744 | LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER Covidien | GEI |
| Apr 5, 2013 | K123429 | OLYMPUS ENERGY POWER SYSTEM (EPS) Gyrus Acmi, Inc. | GEI |
| Apr 5, 2013 | K123353 | CIQ CONTROLLER, CIQ WANDS ArthroCare Corporation | GEI |
| Mar 27, 2013 | K124029 | MICROLINE FLEXIBLE LIGATING SHEARS Microline Surgical, Inc. | GEI |
| Mar 22, 2013 | K130596 | CAIMAN SEAL AND CUT TECHNOLOGY Aesculap, Inc. | GEI |
| Jan 30, 2013 | K123444 | LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER Covidien, Formerly Valleylab, A Division of Tyco H | GEI |
| Jan 25, 2013 | K122797 | ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW Ethicon Endo-Surgery, LLC | GEI |
| Jan 23, 2013 | K123310 | FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) Utah Medical Products, Inc. | GEI |
| Jan 10, 2013 | K123201 | AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER Medtronic Advanced Energy, LLC | GEI |
| Jan 10, 2013 | K122383 | EM3 AEM MONITOR AEM CONNECTORS Encision, Inc. | GEI |
| Dec 21, 2012 | K123260 | DETACHATIP III Conmed Corporation | GEI |
| Dec 21, 2012 | K123172 | KOGENT BIPOLAR FORCEPS Katalyst Surgical, LLC | GEI |
| Dec 11, 2012 | K120791 | AMBIENT TURBOFLASH 90 IFS Arthocare Corporation | GEI |
| Dec 7, 2012 | K120454 | SAFEAIR SMOKE PENCIL, Lna Medical Aps | GEI |
| Nov 20, 2012 | K121977 | PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM Plasma Surgical Limited, GB | GEI |
| Nov 20, 2012 | K121085 | HET BIPOLAR LIGATOR SYSTEM Het Systems, LLC | GEI |
| Nov 15, 2012 | K113380 | PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR Medtronic, Inc. | GEI |
| Nov 9, 2012 | K122580 | AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES Encision, Inc. | GEI |
| Nov 7, 2012 | K122278 | BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR Baylis Medical Company, Inc., CA | GEI |
| Nov 5, 2012 | K122425 | VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT Depuy Mitek, A Johnson & Johnson Company | GEI |
| Nov 2, 2012 | K120909 | EC 2.7 ENDOSCOPIC CUTTER Medtronic Advanced Energy, LLC | GEI |
| Oct 25, 2012 | K123141 | ENSEAL TRIO TISSUE SEALING DEVICE Ethicon Endo-Surgery, LLC | GEI |
| Oct 23, 2012 | K122092 | MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM Medrange Corporation | GEI |
| Oct 1, 2012 | K120116 | SERF ABLATION SYSTEM SERF ABLATION NEEDLE Thermedical | GEI |
| Sep 21, 2012 | K121150 | ALMA LASERS FAMILY OF PIXEL RF TIPS Alma Lasers, Inc. | GEI |
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