FDA Product Code
FDA Product Code GEI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4400
510(k) Clearances — 2,319 records · page 8 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K132199 | DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST | Deroyal Industries, Inc. | 2013-10-03 | Traditional | PDF ↗ |
| K130983 | GENII ARC SMART ARGON PROBE | Genii, Inc. | 2013-09-26 | Traditional | PDF ↗ |
| K132665 | PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC | Ellman International, Inc. | 2013-09-25 | Traditional | PDF ↗ |
| K130760 | ELECTROSURGICAL GENERATOR | Beijing Jinhengwei Technology Development Co., Ltd. | 2013-09-16 | Traditional | PDF ↗ |
| K132136 | SINGLE USE GROUNDING PAD | Lccs Products Limited | 2013-09-06 | Traditional | PDF ↗ |
| K132431 | THERMAGE CPT SYSTEM | Solta Medical, Inc. | 2013-09-06 | Special | PDF ↗ |
| K132374 | BAYLIS MEDICAL RF PERFORATION PROBE V2.0 | Baylis Medical Company, Inc. | 2013-08-30 | Special | PDF ↗ |
| K131949 | AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES | Encision, Inc. | 2013-08-26 | Traditional | PDF ↗ |
| K131012 | SUTTER BIPOLAR FORCEPS - SUPERGLISS | Sutter Medizintechnik GmbH | 2013-08-23 | Traditional | PDF ↗ |
| K132099 | ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND | ArthroCare Corporation | 2013-08-22 | Traditional | PDF ↗ |
| K130027 | DISPOSABLE NEUTRAL ELECTRODE GP202 | Cathay Manufacturing Corp. | 2013-08-22 | Traditional | PDF ↗ |
| K130793 | NEWA SKIN THERAPY SYSTEM | Endymion Medical, Ltd. | 2013-08-16 | Traditional | PDF ↗ |
| K123061 | ACE MONOPOLAR ATTACHMENT | Bioeconeer, Inc. | 2013-08-13 | Traditional | PDF ↗ |
| K131205 | ARTHROCARE HEAD AND NECK COBLATION WAND | ArthroCare Corporation | 2013-08-09 | Traditional | PDF ↗ |
| K120510 | TRANSCEND | Syneron Medical, Ltd. | 2013-07-19 | Traditional | PDF ↗ |
| K123366 | SURGITRON 4.0 DUAL RF S5-IEC | Ellman International, Inc. | 2013-07-12 | Traditional | PDF ↗ |
| K122652 | ARTHROCARE TURBINATOR WAND | ArthroCare Corporation | 2013-07-02 | Traditional | PDF ↗ |
| K121481 | INFINI RADIOFREQUENCY SYSTEM | Lutronic Corporation | 2013-06-25 | Traditional | PDF ↗ |
| K123662 | THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM | Justright Surgical, LLC | 2013-05-22 | Traditional | PDF ↗ |
| K123478 | STINGRAY BIPOLAR FORCEPS | Stingray Surgical Products | 2013-05-10 | Special | PDF ↗ |
| K122200 | A3F FRATIONAL | Pollogen, Ltd. | 2013-04-18 | Traditional | PDF ↗ |
| K122716 | PLASMATRODE SALINE SAFE TUR ELECTRODE | Cook Ireland, Ltd. | 2013-04-17 | Traditional | PDF ↗ |
| K122966 | XP200 | Btl Industries, Ltd. | 2013-04-08 | Traditional | PDF ↗ |
| K130744 | LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER | Covidien | 2013-04-05 | Special | PDF ↗ |
| K123353 | CIQ CONTROLLER, CIQ WANDS | ArthroCare Corporation | 2013-04-05 | Traditional | PDF ↗ |
| K123429 | OLYMPUS ENERGY POWER SYSTEM (EPS) | Gyrus Acmi, Inc. | 2013-04-05 | Traditional | PDF ↗ |
| K124029 | MICROLINE FLEXIBLE LIGATING SHEARS | Microline Surgical, Inc. | 2013-03-27 | Traditional | PDF ↗ |
| K130596 | CAIMAN SEAL AND CUT TECHNOLOGY | Aesculap, Inc. | 2013-03-22 | Special | PDF ↗ |
| K123444 | LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER | Covidien, Formerly Valleylab, A Division of Tyco H | 2013-01-30 | Traditional | PDF ↗ |
| K122797 | ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW | Ethicon Endo-Surgery, LLC | 2013-01-25 | Traditional | PDF ↗ |
| K123310 | FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) | Utah Medical Products, Inc. | 2013-01-23 | Traditional | PDF ↗ |
| K122383 | EM3 AEM MONITOR AEM CONNECTORS | Encision, Inc. | 2013-01-10 | Traditional | PDF ↗ |
| K123201 | AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER | Medtronic Advanced Energy, LLC | 2013-01-10 | Traditional | PDF ↗ |
| K123260 | DETACHATIP III | Conmed Corporation | 2012-12-21 | Traditional | PDF ↗ |
| K123172 | KOGENT BIPOLAR FORCEPS | Katalyst Surgical, LLC | 2012-12-21 | Traditional | PDF ↗ |
| K120791 | AMBIENT TURBOFLASH 90 IFS | Arthocare Corporation | 2012-12-11 | Special | PDF ↗ |
| K120454 | SAFEAIR SMOKE PENCIL, | Lna Medical Aps | 2012-12-07 | Traditional | PDF ↗ |
| K121085 | HET BIPOLAR LIGATOR SYSTEM | Het Systems, LLC | 2012-11-20 | Traditional | PDF ↗ |
| K121977 | PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM | Plasma Surgical Limited | 2012-11-20 | Traditional | PDF ↗ |
| K113380 | PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR | Medtronic, Inc. | 2012-11-15 | Traditional | PDF ↗ |
| K122580 | AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES | Encision, Inc. | 2012-11-09 | Traditional | PDF ↗ |
| K122278 | BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR | Baylis Medical Company, Inc. | 2012-11-07 | Traditional | PDF ↗ |
| K122425 | VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT | Depuy Mitek, A Johnson & Johnson Company | 2012-11-05 | Traditional | PDF ↗ |
| K120909 | EC 2.7 ENDOSCOPIC CUTTER | Medtronic Advanced Energy, LLC | 2012-11-02 | Traditional | PDF ↗ |
| K123141 | ENSEAL TRIO TISSUE SEALING DEVICE | Ethicon Endo-Surgery, LLC | 2012-10-25 | Special | PDF ↗ |
| K122092 | MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM | Medrange Corporation | 2012-10-23 | Traditional | PDF ↗ |
| K120116 | SERF ABLATION SYSTEM SERF ABLATION NEEDLE | Thermedical | 2012-10-01 | Traditional | PDF ↗ |
| K121150 | ALMA LASERS FAMILY OF PIXEL RF TIPS | Alma Lasers, Inc. | 2012-09-21 | Traditional | PDF ↗ |
| K113407 | SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS | Carefusion 2200, Inc. | 2012-09-07 | Traditional | PDF ↗ |
| K113572 | LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER | Covidien, Formerly Valleylab, A Division of Tyco H | 2012-09-05 | Traditional | PDF ↗ |
| K122086 | THERMAL LIGATING SHEARS | Microline Surgical, Inc. | 2012-08-23 | Traditional | PDF ↗ |
| K121426 | AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS | Synergetics, Inc. | 2012-07-10 | Traditional | PDF ↗ |
| K120581 | SC TIP CLEANER | Nsi | 2012-06-29 | Traditional | PDF ↗ |
| K121290 | AQUAMANTRYS3 BSC 9.1S | Medtronic, Inc. | 2012-06-25 | Traditional | PDF ↗ |
| K120527 | ALPHA ORTHOPAEDICS AT2 SYSTEM | Alpha Orthopaedics, Inc. | 2012-06-18 | Traditional | PDF ↗ |
| K120476 | MACROLYTE DISPERSIVE ELECTRODE | Conmed Corporation | 2012-06-12 | Special | PDF ↗ |
| K120322 | CONMED SUREFIT DUAL DISPERSIVE ELECTRODE | Conmed Corporation | 2012-06-12 | Special | PDF ↗ |
| K113597 | MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES | Minilap Technologies | 2012-06-03 | Traditional | PDF ↗ |
| K111262 | ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP | Olsen Medical | 2012-05-23 | Traditional | PDF ↗ |
| K120537 | AQUAMANTYS3 9.5 XL BIPOLAR SEALER | Medtronic, Inc. | 2012-05-10 | Special | PDF ↗ |
| K120431 | HALO90 ULTRA ABLATION CATHETER | Barrx Medical, Inc. | 2012-05-03 | Traditional | PDF ↗ |
| 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 | 2012-04-06 | Traditional | PDF ↗ |
| K120416 | INSULATION TESTER | Spectrum Surgical Supply Corp. | 2012-03-27 | Traditional | PDF ↗ |
| K113265 | GENII GI 4000 ELECTROSUGICAL GENERATOR | Genii, Inc. | 2012-03-22 | Traditional | PDF ↗ |
| K113090 | LEVEEN SUPERSLIM NEEDLE ELECTRODE | Boston Scientific Corporation | 2012-03-15 | Traditional | PDF ↗ |
| K111523 | OSTEOCOOL (TM) RF ABLATION SYSTEM | Baylis Medical Co., Inc. | 2012-03-13 | Traditional | PDF ↗ |
| K111670 | VENUS FREEZE (MP)2 SYSTEM | Venus Concept , Ltd. | 2012-03-02 | Traditional | PDF ↗ |
| 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 | 2012-02-27 | Traditional | PDF ↗ |
| K112233 | BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE | Bovie Medical Corporation | 2012-01-27 | Traditional | PDF ↗ |
| K111986 | LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM | Surgical Innovations Plc | 2012-01-26 | Traditional | PDF ↗ |
| K111202 | SURGICAL TISSUE MANAGEMENT SYSTEM | Olympus Medical Systems Corp. | 2012-01-20 | Traditional | PDF ↗ |
| K112454 | HALO60 ABLATION CATHETER | Barrx Medical, Inc. | 2012-01-05 | Special | PDF ↗ |
| K102921 | ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES | Bema-GmbH & Co. KG | 2011-12-20 | Traditional | PDF ↗ |
| K103508 | UNMIAX LAPAROSCOPIC INSTRUMENT | Unimax Medical Systems, Inc. | 2011-12-20 | Traditional | PDF ↗ |
| K113500 | CANADY VIEIRA HYBRID PLASMA SCALPEL | Us Medical Innovations, LLC | 2011-12-09 | Traditional | PDF ↗ |
| K110924 | DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS | Synergetics, Inc. | 2011-12-07 | Traditional | PDF ↗ |
| K111732 | AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER | Salient Surgical Technologies, Inc. | 2011-12-05 | Traditional | PDF ↗ |
| K111026 | APOLLO | Pollogen, Ltd. | 2011-11-16 | Traditional | PDF ↗ |
| K102752 | STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS | Stingray Surgical Products, Inc. | 2011-11-09 | Traditional | PDF ↗ |
| K112033 | ENSEAL G2 TISSUS SEALERS | Ethicon Endo-Sugery, LLC | 2011-11-08 | Traditional | PDF ↗ |
| K111784 | VENUS SWAN SYSTEM | Venus Concept , Ltd. | 2011-10-07 | Traditional | PDF ↗ |
| K110672 | ETWO SKIN TREATMENT SYSTEM | Syneron, Ltd. | 2011-10-03 | Traditional | PDF ↗ |
| K111412 | SURGISTEER SCISSORS, SURGISTEER DISSECTOR / GRASPER, SURGISTEER HOOK | Steerable Technologix | 2011-09-30 | Traditional | PDF ↗ |
| K110462 | KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE | Kepler Medtec | 2011-09-26 | Traditional | PDF ↗ |
| K111285 | AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING | Salient Surgical Technologies, Inc. | 2011-09-09 | Traditional | PDF ↗ |
| K111887 | CLOSUREFAST RADIOFREQUENCY CATHETER | Covidien | 2011-09-09 | Special | PDF ↗ |
| K110439 | DOMAIN SURGICAL SYSTEM | Domain Surgical, Inc. | 2011-07-18 | Traditional | PDF ↗ |
| K110824 | ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT | Aragon Surgical, Inc. | 2011-07-11 | Traditional | PDF ↗ |
| K111672 | MAX ORIENT SUCTION DEVICE FOR ELECTROCAUTERIZER | Pacific Hospital Supply Co., Ltd. | 2011-06-29 | Traditional | PDF ↗ |
| K110695 | BIPOLAR HF DEVICE | Aesculap, Inc. | 2011-06-28 | Traditional | PDF ↗ |
| K101990 | ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11 | Ethicon Endo-Sugery, LLC | 2011-06-13 | Traditional | PDF ↗ |
| K110143 | HET BIPOLAR ELECTROCAUTERY FORCEPS | Het Systems, LLC | 2011-06-02 | Traditional | PDF ↗ |
| K102461 | FRACTORA | Invasix , Ltd. | 2011-06-02 | Traditional | PDF ↗ |
| K110268 | FORCETRIAD ELECTROSURGICAL GENERATOR | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2011-05-31 | Traditional | PDF ↗ |
| K103775 | PEAK SUCTION COAGULATOR | Peak Surgical, Inc. | 2011-05-27 | Traditional | PDF ↗ |
| K102913 | FORCETRIAD | Covidien, Formerly Valleylab, A Division of Tyco H | 2011-05-06 | Special | PDF ↗ |
| K100669 | CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES | Us Medical Innovations, LLC | 2011-04-06 | Traditional | PDF ↗ |
| K101057 | AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1 | Salient Surgical Technologies | 2011-04-05 | Traditional | PDF ↗ |
| K102275 | THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240 | Thermedx, LLC | 2011-03-25 | Traditional | PDF ↗ |
| K103375 | PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL | Medtek Devices, Inc. | 2011-03-16 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.