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 9 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K103840 | CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE | Flexbar Machine Corp. | 2011-02-28 | Traditional | PDF ↗ |
| K103665 | CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O | Conmed Corporation | 2011-02-16 | Traditional | PDF ↗ |
| K102470 | LUGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER | Covidien, Formerly Valleylab, | 2011-02-07 | Traditional | PDF ↗ |
| K103707 | VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE | Vectec | 2011-02-04 | Traditional | PDF ↗ |
| K103017 | MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE | Mederi Therapeutics, Inc. | 2011-01-20 | Traditional | PDF ↗ |
| K103032 | ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ | Olympus Winter & Ibe GmbH | 2011-01-14 | Traditional | PDF ↗ |
| K102698 | PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE | Ellman Int'L, Inc. | 2011-01-05 | Special | PDF ↗ |
| K102709 | PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE | Peak Surgical, Inc. | 2010-12-17 | Special | PDF ↗ |
| K102029 | PEAK PULSAR II GENERATOR MODEL PS100-102 | Peak Surgical, Inc. | 2010-12-16 | Special | PDF ↗ |
| K101520 | ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH | Ethicon Endo-Surgery, Inc. | 2010-12-10 | Traditional | PDF ↗ |
| K100586 | VENUS FREEZE SYSTEM | Venus Concept , Ltd. | 2010-11-29 | Traditional | PDF ↗ |
| K101534 | CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM | Conmedcorp | 2010-11-24 | Traditional | PDF ↗ |
| K102114 | MEDRANGE ELECTROSURGICAL GENERATOR | Medrange Corporation | 2010-11-22 | Traditional | PDF ↗ |
| K103282 | LAPAROSCOPIC DISSECTOR | Applied Medical Resources Corp. | 2010-11-16 | Traditional | PDF ↗ |
| K102372 | OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB | Jiangmen City Xinhui Baisheng Medical Equipment CO | 2010-11-03 | Traditional | PDF ↗ |
| K102983 | VASCUCLEAR PRECISION BIPOLAR | Sorin Group USA, Inc. | 2010-11-01 | Special | PDF ↗ |
| K102368 | NON-ABLATIVE WRINKLE TREATMENT HANDPIECE | Ellman Int'L, Inc. | 2010-09-07 | Special | PDF ↗ |
| K100390 | SURGIMAX/ SURGIMAX PLUS | Elliquence, LLC | 2010-08-25 | Traditional | PDF ↗ |
| K093622 | AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 | Encision, Inc. | 2010-08-20 | Traditional | PDF ↗ |
| K101967 | NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE' | Ellman Int'L, Inc. | 2010-08-12 | Special | PDF ↗ |
| K091310 | ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 | Dfine, Inc. | 2010-08-11 | Traditional | PDF ↗ |
| K100543 | MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01 | Medisiss | 2010-07-23 | Traditional | PDF ↗ |
| K101108 | ERBE ESU MODEL VIO 100 C WITH ACCESSORIES | Erbe USA, Inc. | 2010-07-16 | Special | PDF ↗ |
| K101711 | CERULEAU ELECTROSURGICAL PROBE | Nuortho Surgical, Inc. | 2010-07-01 | Traditional | PDF ↗ |
| K100816 | PK SUPERPULSE SYSEM GENERATOR MODEL 744000 | Gyrus Acmi, Inc. | 2010-07-01 | Traditional | PDF ↗ |
| K093108 | STRYKER BIPOLAR FORCEPS | Stryker Leibinger GmbH & Co KG | 2010-06-22 | Traditional | PDF ↗ |
| K100333 | FIAB SPA, MODELS F7244, F7233, F7234, F7277 | Fiab Spa | 2010-06-21 | Traditional | PDF ↗ |
| K101080 | NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX | Egon Faulhaber Surgical Instruments Pinzetten | 2010-06-21 | Traditional | PDF ↗ |
| K101111 | HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200 | Barrx Medical, Inc. | 2010-06-18 | Special | PDF ↗ |
| K100638 | VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214 | Depuy Mitek, A Johnson & Johnson Company | 2010-06-18 | Traditional | PDF ↗ |
| K100896 | GYRUS ACMI HALO PKS CUTTING FORCEPS | Gyrus Acmi, Inc. | 2010-06-17 | Special | PDF ↗ |
| K094009 | HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI | Halt Medical, Inc. | 2010-06-14 | Traditional | PDF ↗ |
| K101274 | VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM | Maquet Cardiovascular, LLC | 2010-06-11 | Traditional | PDF ↗ |
| K100711 | SUCTION IRRIGATION ELECTRODES AND ADAPTERS | Encision, Inc. | 2010-06-09 | Traditional | PDF ↗ |
| K100686 | CONMED MACROLYTE DISPERSIVE ELECTRODE | Conmed Corporation | 2010-05-21 | Special | PDF ↗ |
| K100047 | SUREFIT DUAL DISPERSIVE ELECTRODE | Conmed Corporation | 2010-05-14 | Special | PDF ↗ |
| K100353 | SPINEWAND SURGICAL DEVICE | Arthrocare Corp. | 2010-05-13 | Special | PDF ↗ |
| K100258 | ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200 | Wickimed Supply Limited | 2010-04-28 | Abbreviated | PDF ↗ |
| K093511 | SORING MBC200/BCC140 | Soring GmbH Medizintechnik | 2010-04-16 | Traditional | PDF ↗ |
| K093695 | PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE | Peak Surgical, Inc. | 2010-04-13 | Special | PDF ↗ |
| K094041 | ALPHA ORTHOPAEDICS AT3 SYSTEM | Alpha Orthopaedics | 2010-04-07 | Traditional | PDF ↗ |
| K100224 | ESTECH COBRA BIPOLSR II | Endoscopic Technologies, Inc. D/B/A Estech | 2010-04-07 | Traditional | PDF ↗ |
| K100641 | INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET) | Relievant Medsystems | 2010-03-30 | Special | PDF ↗ |
| K092149 | BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215 | Bovie Medical | 2010-03-18 | Traditional | PDF ↗ |
| K092383 | BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300 | Bovie Medical Corporation | 2010-03-10 | Traditional | PDF ↗ |
| K093203 | CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841 | Medtronic, Inc. | 2010-02-26 | Special | PDF ↗ |
| K093086 | ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080 | Orthodynamix, LLC | 2010-02-23 | Traditional | PDF ↗ |
| K093075 | ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENT | Aragon Surgical, Inc. | 2010-01-21 | Traditional | PDF ↗ |
| K091674 | ARTHROCARE COBLATOR IQ SYSTEM | Arthrocare Corp. | 2010-01-15 | Traditional | PDF ↗ |
| K093855 | HALO 360 & SIZING BALLOON, MODEL 3441C | Barrx Medical, Incorporated | 2010-01-15 | Special | PDF ↗ |
| K091259 | ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS | Ethicon Endo-Surgery, Inc. | 2010-01-15 | Traditional | PDF ↗ |
| K093008 | HALO ABLATION CATHETER, MODEL 90-9100 | Barrx Medical, Incorporated | 2010-01-08 | Traditional | PDF ↗ |
| K090025 | MATRIX RF APPLICATOR | Syneron Medical, Ltd. | 2010-01-08 | Traditional | PDF ↗ |
| K093025 | BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES | Bovie Medical Corporation | 2009-12-22 | Traditional | PDF ↗ |
| K093165 | ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS | Arthrocare Corp. | 2009-12-04 | Special | PDF ↗ |
| K091672 | DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES | Shuyou Electric Medical Science Co., Ltd. | 2009-12-04 | Traditional | PDF ↗ |
| K092634 | OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF | Jiangmen City Xinhui Baisheng Medical Equipment CO | 2009-12-01 | Traditional | PDF ↗ |
| K091824 | ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507 | Ethicon Endo-Surgery, Inc. | 2009-11-27 | Traditional | PDF ↗ |
| K092732 | PROPENCIL ESU PENCIL | Bio Protech, Inc. | 2009-11-25 | Traditional | PDF ↗ |
| K092191 | EXILIS, MODEL 5000 | Btl Industries, Ltd. | 2009-11-25 | Traditional | PDF ↗ |
| K092761 | PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C | Bio Protech, Inc. | 2009-11-24 | Special | PDF ↗ |
| K083754 | MINI LAP ELECTROCAUTERY INSTRUMENTS | Mini Lap Technologies, Inc. | 2009-11-20 | Traditional | PDF ↗ |
| K092487 | HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A | Barrx Medical, Incorporated | 2009-11-10 | Traditional | PDF ↗ |
| K092009 | MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260, M001262270, M001262280, M001262290 | Boston Scientific Corporation | 2009-11-06 | Special | PDF ↗ |
| K091290 | ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508 | Ethicon Endo-Surgery, Inc. | 2009-10-29 | Traditional | PDF ↗ |
| K082584 | GIVEN ELECTROSURGICAL NEEDLE | Tripps Court Enterprises, Inc. | 2009-10-28 | Traditional | PDF ↗ |
| K092879 | LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER | Valleylab | 2009-10-16 | Special | PDF ↗ |
| K091440 | LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L | Bovie Medical | 2009-10-09 | Traditional | PDF ↗ |
| K091228 | SPINEWAND SURGICAL DEVICE | Arthrocare Corp. | 2009-09-28 | Special | PDF ↗ |
| K091223 | VALLEYLAB SUCTION COAGULATOR, MODEL E3305 | Covidien LP | 2009-09-11 | Traditional | PDF ↗ |
| K082391 | PRIMAEVA MEDICAL RENESIS SYSTEM | Primaeva Medical, Inc. | 2009-09-01 | Traditional | PDF ↗ |
| K090309 | LAGIS ENDOSCOPIC INSTRUMENTS | Lagis Enterprises Co, Ltd. | 2009-08-28 | Traditional | PDF ↗ |
| K091733 | VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500 | Maquet Cardiovascular, LLC | 2009-08-28 | Special | PDF ↗ |
| K083608 | ERBE HYBRID KNIFE | Erbe USA, Inc. | 2009-08-26 | Traditional | PDF ↗ |
| K091074 | AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES | Encision, Inc. | 2009-08-17 | Traditional | PDF ↗ |
| K080844 | G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE | Gyrus Acmi, Inc. | 2009-08-13 | Traditional | PDF ↗ |
| K090586 | BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R), REUSABLE HANDPIECE CABLE (GS807-RC) | Bovie Medical | 2009-08-07 | Traditional | PDF ↗ |
| K083461 | IMAGINE TC SKIN THERAPY SYSTEM | Endymion Medical, Ltd. | 2009-07-24 | Traditional | PDF ↗ |
| K090580 | THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES | Solta Medical, Inc. | 2009-06-26 | Traditional | PDF ↗ |
| K090393 | ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS, MODEL 72202139,72202141, 72202143, 72202144 | Arthrocare Corp. | 2009-06-23 | Traditional | PDF ↗ |
| K083895 | CODMAN ISOCOOL BIPOLAR FORCEPS | Codman & Shurtleff, Inc. | 2009-06-23 | Traditional | PDF ↗ |
| K090306 | ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT | Aragon Surgical, Inc. | 2009-06-18 | Traditional | PDF ↗ |
| K082505 | KLS MARTIN ELECTROSURGICAL INSTRUMENTS | Kl Martin L.P. | 2009-06-12 | Traditional | PDF ↗ |
| K083415 | PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE | Peak Surgical, Inc. | 2009-06-05 | Traditional | PDF ↗ |
| K082834 | ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC | Ellman Int'L, Inc. | 2009-05-07 | Traditional | PDF ↗ |
| K091107 | MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM | Hemostatix Medical Technologies, LLC | 2009-05-01 | Traditional | PDF ↗ |
| K083590 | ISKRA MEDICAL GREEN IRF PRESTIGE | Iskra Medical, D.O.O. | 2009-04-17 | Traditional | PDF ↗ |
| K083281 | EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA- | Linvatec Corp. | 2009-02-25 | Traditional | PDF ↗ |
| K083737 | HALO ABLATION CATHETER | Barrx Medical, Incorporated | 2009-02-10 | Special | PDF ↗ |
| K081398 | ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES | Advanced Medical Innovations, Inc. | 2009-02-06 | Traditional | PDF ↗ |
| K083711 | MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34 | Barrx Medical, Incorporated | 2009-02-02 | Special | PDF ↗ |
| K083528 | SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022 | Smith & Nephew, Inc. | 2009-01-28 | Traditional | PDF ↗ |
| K083856 | INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, FG0026 | Relievant Medsystems, Inc. | 2009-01-22 | Special | PDF ↗ |
| K082955 | ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505 | Ethicon Endo-Surgery, Inc. | 2009-01-15 | Traditional | PDF ↗ |
| K083162 | STINGRAY ELECTROSURGICAL FORCEPS | Stingray Surgical Products, Inc. | 2009-01-12 | Traditional | PDF ↗ |
| K083452 | ERBE MODEL VIO 300 D WITH ACCESSORIES | Erbe USA, Inc. | 2008-12-31 | Special | PDF ↗ |
| K082643 | 3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE | Depuy Mitek, A Johnson & Johnson Company | 2008-12-19 | Special | PDF ↗ |
| K082956 | ALPHA ORTHOPAEDICS AT2 SYSTEM | Alpha Orthopaedics | 2008-12-18 | Traditional | PDF ↗ |
| K080741 | MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE | Megadyne Medical Products, Inc. | 2008-12-16 | Traditional | PDF ↗ |
| K082902 | RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES | Rz Medizintechnik GmbH | 2008-12-10 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.