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 15 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K000496 | EVERSHEARS BIPOLAR SCISSORS | Everest Medical Corp. | 2000-04-24 | Traditional | PDF ↗ |
| K000936 | VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM | Mitek Products | 2000-04-19 | Special | PDF ↗ |
| K000961 | AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE | Aaron Medical Industries | 2000-04-19 | Special | PDF ↗ |
| K000245 | CSM STRETTA SYSTEM | Conway Stuart Medical, Inc. | 2000-04-18 | Traditional | PDF ↗ |
| K000241 | RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR | Radiotherapeutics Corp. | 2000-04-14 | Traditional | PDF ↗ |
| K000911 | MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057 | Hysterx, Inc. | 2000-04-14 | Special | PDF ↗ |
| K982556 | LEVEEN NEEDLE ELECTRODE | Radiotherapeutics Corp. | 2000-04-06 | Traditional | PDF ↗ |
| K993412 | BITX PROBES | Everest Medical Corp. | 2000-03-31 | Traditional | PDF ↗ |
| K000032 | LEVEEN NEEDLE ELECTRODE | Radiotherapeutics Corp. | 2000-03-30 | Traditional | PDF ↗ |
| K994319 | MODULAP | Atc Technologies, Inc. | 2000-03-20 | Traditional | PDF ↗ |
| K992180 | VISAGE COSMETIC SURGERY, MODEL V5000 | Arthrocare Corp. | 2000-03-20 | Traditional | PDF ↗ |
| K000501 | ELECTROSURGICAL GENERATOR, MODEL S1 | Somnus Medical Technologies, Inc. | 2000-03-17 | Traditional | PDF ↗ |
| K000511 | MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINE WANDS | Arthrocare Corp. | 2000-03-13 | Special | PDF ↗ |
| K994365 | DYONICS ELECTROBLADE | Smith & Nephew, Inc. | 2000-03-13 | Traditional | PDF ↗ |
| K000250 | CAUTERY FORCEPS WITH FOOTSWITCH | Starion Instruments | 2000-03-07 | Traditional | PDF ↗ |
| K994428 | E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE | Valleylab, Inc. | 2000-03-07 | Abbreviated | PDF ↗ |
| K000296 | STARION CAUTERY HOOK | Starion Instruments | 2000-03-07 | Traditional | PDF ↗ |
| K000228 | ENTEC CONTROLLER, ENTEC PATIENT CABLE, FOOTSWITCH, POWERCORD, PLASMA WAND | Arthrocare Corp. | 2000-02-22 | Special | PDF ↗ |
| K000170 | SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000 | Conway Stuart Medical, Inc. | 2000-02-14 | Special | PDF ↗ |
| K994336 | BITX PROBES | Everest Medical Corp. | 2000-02-08 | Traditional | PDF ↗ |
| K000036 | ENTEC REFLEX WAND 55, MODEL E4055-00 | Arthrocare Corp. | 2000-02-04 | Traditional | PDF ↗ |
| K000074 | ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA SCALPEL GS, TURBOVAC GS | Arthrocare Corp. | 2000-02-04 | Special | PDF ↗ |
| K992805 | ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES) | Oratec Interventions, Inc. | 2000-02-04 | Traditional | PDF ↗ |
| K000044 | ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINEWANDS | Arthrocare Corp. | 2000-02-01 | Special | PDF ↗ |
| K992045 | ELECTROSURGICAL ELECTRODE FAMILY | Genesis Medical, Inc. | 2000-01-27 | Traditional | PDF ↗ |
| K994173 | STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTECH RADIOFREQUENCY GENERATOR, MODEL 1025A-230 | Stellartech Research Corp. | 2000-01-20 | Abbreviated | PDF ↗ |
| K994333 | ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES | Oratec Interventions, Inc. | 2000-01-18 | Special | PDF ↗ |
| K994075 | GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435 | Geiger Medical Technologies, Inc. | 1999-12-27 | Traditional | PDF ↗ |
| K993655 | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS | Xomed, Inc. | 1999-12-21 | Traditional | PDF ↗ |
| K993967 | ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002 | Oratec Interventions, Inc. | 1999-12-17 | Special | PDF ↗ |
| K993112 | XOMED ENT RF SYSTEM | Xomed, Inc. | 1999-12-09 | Traditional | PDF ↗ |
| K992581 | ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, SPINE WANDS, ORTHOWANDS, ARTHROWANDS | Arthrocare Corp. | 1999-12-09 | Traditional | PDF ↗ |
| K993854 | ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES | Oratec Interventions, Inc. | 1999-12-06 | Special | PDF ↗ |
| K993944 | RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE, DISPERSIVE ELECTRODE | Rita Medical Systems | 1999-12-02 | Traditional | PDF ↗ |
| K992996 | ENABLE ENDOSCOPIC BIPOLAR SCISSORS | Enable Medical Corp. | 1999-11-24 | Traditional | PDF ↗ |
| K992931 | NON-STICK BIPOLAR FORCEPS | Silverglide Surgical Technologies | 1999-11-17 | Traditional | PDF ↗ |
| K993647 | UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F | Unimed Surgical Products, Inc. | 1999-11-16 | Special | PDF ↗ |
| K992542 | TUBULAR ELECTRODE DEVICE | Conway Stuart Medical, Inc. | 1999-10-27 | Traditional | PDF ↗ |
| K992760 | SELECT-SUTTER MICRO BIPOLAR FORCEPS | Select Medizintechnik Hermann Sutter GmbH | 1999-10-25 | Traditional | PDF ↗ |
| K991140 | ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES | Oratec Interventions, Inc. | 1999-10-25 | Traditional | PDF ↗ |
| K993265 | SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600 | Soring GmbH Medizintechnik | 1999-10-22 | Special | PDF ↗ |
| K992764 | ERBE APC RASPATORY HANDLE AND TIP, MODEL 20132-102, 20132-103 | Erbe USA, Inc. | 1999-10-14 | Traditional | PDF ↗ |
| K992769 | ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013- | Erbe USA, Inc. | 1999-10-14 | Traditional | PDF ↗ |
| K992382 | SURGITRON RADIOLASE | Ellman Intl., Inc. | 1999-10-14 | Traditional | PDF ↗ |
| K990723 | DYONICS VARICOSE VEIN ABLATION BLADE | Smith & Nephew, Inc. | 1999-10-05 | Traditional | PDF ↗ |
| K993055 | DEXIDE BIPOLAR FORCEPS II** DEVICE | United States Surgical, A Division of Tyco Healthc | 1999-10-05 | Traditional | PDF ↗ |
| K992714 | MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010 | Hysterx, Inc. | 1999-10-05 | Traditional | PDF ↗ |
| K992460 | CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY | Starion Instruments | 1999-10-05 | Traditional | PDF ↗ |
| K992572 | NTERO RF SLEEVE | Ntero Surgical, Inc. | 1999-09-24 | Traditional | PDF ↗ |
| K992972 | ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROCARE ELECTROSURGERY WAND, MODELS H2000 | Arthrocare Corp. | 1999-09-24 | Special | PDF ↗ |
| K990362 | INSTRUMENT, ULTRASONIC, SCALPEL | Ethicon Endo-Surgery, Inc. | 1999-09-17 | Traditional | PDF ↗ |
| K991529 | CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400 | Conway Stuart Medical, Inc. | 1999-09-14 | Traditional | PDF ↗ |
| K972267 | HELICA TC | Tenerco, Inc. | 1999-09-14 | Traditional | PDF ↗ |
| K991218 | ORATEC BIPOLAR ABLATION PROBES | Oratec Interventions, Inc. | 1999-09-13 | Traditional | PDF ↗ |
| K992345 | CHRISTOUDIAS SLIM TIP ELECTRODE INSERT | Innervision, Inc. | 1999-09-10 | Traditional | PDF ↗ |
| K992693 | RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90 | Rita Medical Systems | 1999-09-10 | Special | PDF ↗ |
| K992485 | MONOPOLAR ELECTRODES AND CABLES | Us Endo, Inc. | 1999-08-27 | Traditional | PDF ↗ |
| K992149 | GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405 | Geiger Medical Technologies, Inc. | 1999-08-19 | Traditional | PDF ↗ |
| K991960 | SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS HANDPIECE CABLE, SERFAS FOOTSWITCH | Stryker Endoscopy | 1999-08-13 | Traditional | PDF ↗ |
| K991669 | PMS 750 FINGERSWITCH | Wallach Surgical Devices, Inc. | 1999-08-12 | Traditional | PDF ↗ |
| K992406 | VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM | Mitek Products | 1999-08-06 | Special | PDF ↗ |
| K992408 | ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR PROBES | Oratec Interventions, Inc. | 1999-07-30 | Special | PDF ↗ |
| K992218 | DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601 | Kirwan Surgical Products, Inc. | 1999-07-30 | Traditional | PDF ↗ |
| K992186 | QUAD BIPOLAR LAPAROSCOPIC COAGULATING AND CUTTING INSTRUMENT | Conmedcorp | 1999-07-30 | Traditional | PDF ↗ |
| K991291 | STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION | Conway Stuart Medical, Inc. | 1999-07-14 | Traditional | PDF ↗ |
| K991859 | DEXIDE BIPOLAR FORCEPS II ** DEVICE | United States Surgical, A Division of Tyco Healthc | 1999-06-23 | Traditional | PDF ↗ |
| K991814 | MULTACHOICE INSTRUMENTS | Dexide, Inc. | 1999-06-23 | Special | PDF ↗ |
| K991190 | DEFLECTABLE ELECTROSURGICAL PROBES | Oratec Interventions, Inc. | 1999-06-23 | Traditional | PDF ↗ |
| K984240 | ENDOPATH ENDOSCOPIC INSTRUMENTS | Ethicon Endo-Surgery, Inc. | 1999-06-22 | Abbreviated | PDF ↗ |
| K991855 | CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX | Conmedcorp | 1999-06-15 | Special | PDF ↗ |
| K990859 | DEFLECTABLE TAC ELECTROTHERMAL PROBE | Oratec Interventions, Inc. | 1999-06-14 | Traditional | PDF ↗ |
| K990586 | CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES | Conmedcorp | 1999-05-17 | Traditional | PDF ↗ |
| K990474 | ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES | Oratec Interventions, Inc. | 1999-05-17 | Traditional | PDF ↗ |
| K983986 | CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR | Conway Stuart Medical, Inc. | 1999-03-23 | Traditional | PDF ↗ |
| K990146 | SURGITRON | Ellman Intl., Inc. | 1999-03-17 | Traditional | PDF ↗ |
| K982816 | VNUS CLOSURE SYSTEM | Vnus Medical Technologies, Inc. | 1999-03-17 | Traditional | PDF ↗ |
| K984018 | HEMOSLEEVE, MODEL 4.0MM, 5.5MM | Surgical Laser Technologies, Inc. | 1999-03-15 | Traditional | PDF ↗ |
| K984552 | COOL-TIP RF SYSTEM | Radionics, Inc. | 1999-03-05 | Traditional | PDF ↗ |
| K984352 | AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPR | Aaron Medical Industries | 1999-03-04 | Traditional | PDF ↗ |
| K984417 | BIPOLAR GRASPING FORCEPS BIQ+ | Olympus America, Inc. | 1999-02-24 | Traditional | PDF ↗ |
| K983208 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR | Wallach Surgical Devices, Inc. | 1999-02-22 | Traditional | PDF ↗ |
| K984276 | DISPOSABLE ELECTROSURGERY GROUNDING PAD | E & M Engineering, Inc. | 1999-02-10 | Traditional | PDF ↗ |
| K984236 | AARON ESU FOOT-CONTROL ADAPTER #A1205A | Aaron Medical Industries | 1999-02-10 | Traditional | PDF ↗ |
| K984239 | SLICKTIP SOLID LAPAROSCOPIC ELECTRODE, MODELS LH01Z, LB02Z, LN03Z, LC04Z, LS05Z, LL06Z, LJ07Z | Aaron Medical Industries | 1999-02-10 | Traditional | PDF ↗ |
| K984275 | THE GOLDEN TIP ELECTRO-SURGICAL PROBE | Amada Surgical | 1999-02-01 | Traditional | PDF ↗ |
| K983852 | BLUE VALUE LINE OF ELECTROSURGICAL ELECTRODES, MODEL #'S 421-429 | Geiger Medical Technologies, Inc. | 1999-01-28 | Traditional | PDF ↗ |
| K983782 | ELECTROSURGICAL DISPERSIVE ELECTRODE | Conmedcorp | 1999-01-25 | Traditional | PDF ↗ |
| K983743 | BISURE LAPAROSCOPIC BIPOLAR FORCEPS | Valleylab, Inc. | 1999-01-21 | Traditional | PDF ↗ |
| K972335 | CLEANCUT | Medquest Products, Inc. | 1999-01-07 | Traditional | PDF ↗ |
| K983761 | AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5 | Aaron Medical Industries | 1998-12-30 | Traditional | PDF ↗ |
| K984185 | MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY | Oratec Interventions, Inc. | 1998-12-16 | Special | PDF ↗ |
| K981781 | ELECTROSURGICAL UNIT | Hill-Med, Inc. | 1998-12-04 | Traditional | PDF ↗ |
| K983236 | BIPOLAR HF CABLE | Richard Wolf Medical Instruments Corp. | 1998-12-04 | Traditional | PDF ↗ |
| K983116 | ELECTROSURGICAL INFLATABLE BASKET ELECTRODES | Conway Stuart Medical, Inc. | 1998-12-03 | Traditional | PDF ↗ |
| K982212 | VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010 | Synergetics, Inc. | 1998-12-02 | Traditional | PDF ↗ |
| K983871 | RITA MODEL 70 ELECTROSURGICAL PROBE | Rita Medical Systems | 1998-12-01 | Special | PDF ↗ |
| K983788 | AARON COOLPAD SPLIT W/O CORD,AARON COOLPAD SPLIT WITH CORD, AARON COOLPAD W/O CORD, ARRON COOLPAD WITH CORD, MODELS ESRE | Aaron Medical Industries | 1998-11-25 | Traditional | PDF ↗ |
| K982971 | ORATEC TAC-C, MONOPOLAR CAUTERY PROBE | Oratec Interventions, Inc. | 1998-11-23 | Traditional | PDF ↗ |
| K982854 | MR COMPATIBLE LEVEEN NEEDLE ELECTRODE | Radiotherapeutics Corp. | 1998-11-10 | Traditional | PDF ↗ |
| K982826 | MEGA 2000 | Megadyne Medical Products, Inc. | 1998-11-06 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.