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 14 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K013639 | THERMAGE THERMACOOL TC SYSTEM | Thermage, Inc. | 2002-01-29 | Traditional | PDF ↗ |
| K014224 | PRECISION PLUS TUNA OFFICE SYSTEM | Vidamed, Inc. | 2002-01-23 | Special | PDF ↗ |
| K014222 | ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD | Arthrocare Corp. | 2002-01-18 | Special | PDF ↗ |
| K013416 | INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY | Intuitive Surgical, Inc. | 2002-01-10 | Traditional | PDF ↗ |
| K013139 | STELLARTECH COAGULATION SYSTEM | Stellartech Research Corp. | 2001-12-18 | Traditional | PDF ↗ |
| K012631 | REPROCESSED SOFT TISSUE ABLATORS | Alliance Medical Corp. | 2001-12-06 | Traditional | PDF ↗ |
| K013463 | ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND | Arthrocare Corp. | 2001-11-15 | Special | PDF ↗ |
| K012679 | REPROCESSED RF ARTHROSCOPY PROBES | Sterilmed, Inc. | 2001-11-08 | Traditional | PDF ↗ |
| K012725 | TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES | Endo-Therapeutics, Inc. | 2001-11-08 | Traditional | PDF ↗ |
| K013255 | SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF | Ellman Intl., Inc. | 2001-11-07 | Traditional | PDF ↗ |
| K012700 | VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS | Vanguard Medical Concepts, Inc. | 2001-11-07 | Traditional | PDF ↗ |
| K012695 | VANGUARD REPROCESSED ARTHROSCOPIC WANDS | Vanguard Medical Concepts, Inc. | 2001-10-30 | Traditional | PDF ↗ |
| K013348 | MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166 | Erbe USA, Inc. | 2001-10-26 | Special | PDF ↗ |
| K012519 | ARTHROCARE ELECTROSURGERY WANDS | Arthrocare Corp. | 2001-10-25 | Traditional | PDF ↗ |
| K012625 | REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS | Alliance Medical Corp. | 2001-10-22 | Traditional | PDF ↗ |
| K012315 | LEVEEN ELECTRODE | Radiotherapeutics Corp. | 2001-10-11 | Traditional | PDF ↗ |
| K013034 | MODIFICATION TO: THERMACOOL IIA | Thermage, Inc. | 2001-10-04 | Special | PDF ↗ |
| K012986 | BIPOLAR IRRIGATION FORCEPS | Aesculap, Inc. | 2001-10-03 | Special | PDF ↗ |
| K012004 | EASY GUIDE ELECTROSURGICAL ACCESS DEVICE | Senorx, Inc. | 2001-09-25 | Traditional | PDF ↗ |
| K012033 | MULTIFUNCTION ENDOSCOPIC INSTRUMENT | Seedling Enterprises., LLC | 2001-09-20 | Traditional | PDF ↗ |
| K011929 | HANDPIECE SHEATH-MODEL #A910 | Aaron Medical, Inc. | 2001-09-18 | Traditional | PDF ↗ |
| K012799 | ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL | Senorx, Inc. | 2001-09-04 | Traditional | PDF ↗ |
| K012488 | MODIFICATION TO:ENDIUS BIPOLAR SHEATH | Endius, Inc. | 2001-08-30 | Special | PDF ↗ |
| K011722 | ATRICURE BIPOLAR COAGULATION SYSTEM | AtriCure, Inc. | 2001-08-30 | Traditional | PDF ↗ |
| K012129 | ORTHO DEVELOPMENT ORION-I EMF SYSTEM | Ortho Development Corp. | 2001-08-22 | Traditional | PDF ↗ |
| K011279 | ENTEC EVAC PLASMA WAND | Arthrocare Corp. | 2001-07-19 | Traditional | PDF ↗ |
| K011634 | ARTHROCARE CONTROLLER, MODEL H2000; ARTHROCARE CABLE, MODEL H0970-02; FOOTSWITCH, MODEL H2000-04; POWERCORD, MODEL H2000 | Arthrocare Corp. | 2001-06-19 | Special | PDF ↗ |
| K010815 | NTERO NOMAD SYSTEM | Ntero Surgical, Inc. | 2001-06-15 | Traditional | PDF ↗ |
| K003190 | EN BLOC BIOPSY SYSTEM | Neothermia Corp. | 2001-06-11 | Traditional | PDF ↗ |
| K001442 | ESU HANDSWITCHING PENCIL | Surgex, Inc. | 2001-05-31 | Traditional | PDF ↗ |
| K010710 | SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES | Seedling Enterprises., LLC | 2001-05-18 | Traditional | PDF ↗ |
| K010465 | DENSTAT | Elmed, Inc. | 2001-05-14 | Traditional | PDF ↗ |
| K010661 | MODIFICATION TO TISSUELINK BIPOLAR FORCEPS | Tissuelink Medical, Inc. | 2001-05-03 | Traditional | PDF ↗ |
| K010487 | BIPOLAR PENCIL, MODEL 3901-002, 3900-002 | Medtronic PS Medical | 2001-05-03 | Abbreviated | PDF ↗ |
| K010662 | MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL | Tissuelink Medical, Inc. | 2001-04-27 | Traditional | PDF ↗ |
| K010956 | COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X; COBRA FLEX SURGICAL PROBE MODEL 1594X | Boston Scientific Corp | 2001-04-13 | Special | PDF ↗ |
| K003126 | BIPOLAR TRIGGER-FLEX PROBE | Ellman Intl., Inc. | 2001-04-11 | Traditional | PDF ↗ |
| K002000 | MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS; | Richard Wolf Medical Instruments Corp. | 2001-04-10 | Traditional | PDF ↗ |
| K003676 | RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR | Rita Medical Systems | 2001-04-09 | Special | PDF ↗ |
| K002981 | ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150 | Ethicon Endo-Surgery, Inc. | 2001-04-09 | Traditional | PDF ↗ |
| K010265 | BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265 | Baylis Medical Co., Inc. | 2001-04-09 | Traditional | PDF ↗ |
| K010112 | BIPOLAR COAGULATION SYSTEM | Enable Medical Corp. | 2001-04-02 | Traditional | PDF ↗ |
| K010010 | VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR | Valleylab, Inc. | 2001-04-02 | Traditional | PDF ↗ |
| K010192 | ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION | Antyllos Medizintechnik GmbH | 2001-04-02 | Traditional | PDF ↗ |
| K010013 | LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 | Valleylab, Inc. | 2001-03-26 | Traditional | PDF ↗ |
| K003897 | ENDIUS BIPOLAR SHEATH | Endius, Inc. | 2001-03-22 | Traditional | PDF ↗ |
| K003717 | INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF | Tekno Medical Optik-Chirurgie GmbH & Co. | 2001-03-01 | Abbreviated | PDF ↗ |
| K010444 | ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP | C.R. Bard, Inc. | 2001-02-28 | Traditional | PDF ↗ |
| K010025 | ELECTRICATOR MODEL 26000 | Dermatologic Lab & Supply, Inc. | 2001-02-22 | Traditional | PDF ↗ |
| K010210 | CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400 | Curon Medical, Inc. | 2001-02-21 | Special | PDF ↗ |
| K002877 | MICTEC ENDOSCOPES AND ACCESSORIES | Dufner Instrumente GmbH | 2001-02-05 | Abbreviated | PDF ↗ |
| K003773 | CLEAN SCRAPE | Webb Research Ii, Inc. | 2001-02-02 | Traditional | PDF ↗ |
| K010060 | RITA STARBURST XLI ELECTROSURGICAL DEVICE | Rita Medical Systems | 2001-01-23 | Traditional | PDF ↗ |
| K003462 | ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045 | Erbe USA, Inc. | 2001-01-04 | Abbreviated | PDF ↗ |
| K002269 | ELECTROSURGICAL PROBES AND DEVICES-GELTX | Ximed/Prosure/Injectx | 2001-01-04 | Traditional | PDF ↗ |
| K003050 | CRYOSURGICAL UNIT AND ACCESSORIES | Cryogen, Inc. | 2000-12-26 | Traditional | PDF ↗ |
| K001955 | AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250 | Aaron Medical Industries | 2000-12-22 | Traditional | PDF ↗ |
| K003624 | REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWITCH, REFINITY POWER CORD, MODEL V5100-00,V5701-00,V5702 | Arthrocare Corp. | 2000-12-20 | Special | PDF ↗ |
| K003092 | MODIFICATION TO VNUS CLOSURE SYSTEM | Vnus Medical Technologies, Inc. | 2000-12-18 | Special | PDF ↗ |
| K003249 | PST ELECTROSURGICAL GENERATOR, MODEL 2150, PST BIPOLAR FORCEPS, MODEL EBF 1228 | Pst, Inc. | 2000-12-12 | Traditional | PDF ↗ |
| K002841 | COOL-TEC ELECTRODES | Seedling Enterprises., LLC | 2000-12-08 | Traditional | PDF ↗ |
| K003183 | THERMAGE THERMACOOL II SYSTEM | Thermage, Inc. | 2000-12-08 | Traditional | PDF ↗ |
| K003005 | TISSUELINK BIPOLAR FORCEPS | Tissuelink Medical, Inc. | 2000-12-08 | Traditional | PDF ↗ |
| K003674 | NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, NEEDLE TIP, BALL TIP | Davol Inc., Sub. C. R. Bard, Inc. | 2000-12-08 | Traditional | PDF ↗ |
| K003587 | CLEARGLIDE PRECISION BIPOLAR DEVICE | ETHICON, Inc. | 2000-12-04 | Traditional | PDF ↗ |
| K002987 | REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE | Xomed, Inc. | 2000-12-04 | Traditional | PDF ↗ |
| K003471 | MAGNA TEK ESU-400 | Huttinger Medizintechnik GmbH & CO KG | 2000-11-20 | Traditional | PDF ↗ |
| K002752 | BAYONET FORCEPS BIPOLAR IRRIGATING | Q2 Medical | 2000-11-20 | Traditional | PDF ↗ |
| K002680 | TISSUELINK MONOPOLAR FLOATING BALL' | Tissuelink Medical, Inc. | 2000-11-13 | Traditional | PDF ↗ |
| K002582 | PILLING E-FRAZIER BIPOLAR SUCTION TUBE | Pilling | 2000-11-03 | Traditional | PDF ↗ |
| K003060 | PLASMAKINETIC GENERATOR | Everest Medical Corp. | 2000-10-31 | Special | PDF ↗ |
| K002257 | TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 | Tecno Instruments (Pvt.) , Ltd. | 2000-10-19 | Traditional | PDF ↗ |
| K002898 | CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST | Curon Medical, Inc. | 2000-10-17 | Special | PDF ↗ |
| K001986 | SURGITRON IEC II | Ellman Intl., Inc. | 2000-09-27 | Traditional | PDF ↗ |
| K002422 | VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM | Mitek Products | 2000-08-31 | Special | PDF ↗ |
| K002021 | HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE | Gyrus Ent LLC | 2000-08-24 | Traditional | PDF ↗ |
| K002002 | SUREFIT DISPERSIVE ELECTRODE | Conmedcorp | 2000-08-17 | Traditional | PDF ↗ |
| K001407 | SURGITRON IEC II | Ellman Intl., Inc. | 2000-07-24 | Traditional | PDF ↗ |
| K001936 | ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD | Arthrocare Corp. | 2000-07-19 | Special | PDF ↗ |
| K001723 | COOL-TEC ELECTRODES | Seedling Enterprises., LLC | 2000-07-19 | Traditional | PDF ↗ |
| K000944 | THERMAGE THERMACOOL SYSTEM | Thermage, Inc. | 2000-07-19 | Traditional | PDF ↗ |
| K001904 | ARTHROCARE FLOW CONTROL UNIT | Arthrocare Corp. | 2000-07-17 | Special | PDF ↗ |
| K001150 | ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE | Novasys Medical, Inc. | 2000-06-29 | Traditional | PDF ↗ |
| K001382 | AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR | Aaron Medical Industries | 2000-06-27 | Traditional | PDF ↗ |
| K001151 | ELECTROSURGICAL ELECTRODE FAMILY | Novasys Medical, Inc. | 2000-06-27 | Traditional | PDF ↗ |
| K001273 | STARION INSTRUMENTS POWER POINT CAUTERY CLAMP | Starion Instruments | 2000-06-14 | Traditional | PDF ↗ |
| K001262 | THERMAL CAUTERY FORCEPS | Starion Instruments | 2000-06-14 | Traditional | PDF ↗ |
| K001593 | MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL | Chester Labs, Inc. | 2000-06-14 | Special | PDF ↗ |
| K001159 | HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL | Conmedcorp | 2000-06-07 | Traditional | PDF ↗ |
| K001161 | ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL), | Conmedcorp | 2000-06-07 | Traditional | PDF ↗ |
| K993991 | HM-930 ELECTROSURGICAL UNIT | Hill-Med, Inc. | 2000-05-30 | Traditional | PDF ↗ |
| K000720 | SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE | Somnus Medical Technologies, Inc. | 2000-05-30 | Traditional | PDF ↗ |
| K001302 | ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, PLASMA SCALPEL GS, C | Arthrocare Corp. | 2000-05-30 | Traditional | PDF ↗ |
| K001330 | SOVEREIGN BIPOLAR INSTRUMENTS | Aesculap, Inc. | 2000-05-30 | Traditional | PDF ↗ |
| K001253 | SURGITRON IEC II | Ellman Intl., Inc. | 2000-05-26 | Traditional | PDF ↗ |
| K001029 | GEIGER NEEDLE ADAPTER, MODEL 406 | Geiger Medical Technologies, Inc. | 2000-05-23 | Traditional | PDF ↗ |
| K001438 | SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR | Somnus Medical Technologies, Inc. | 2000-05-16 | Special | PDF ↗ |
| K000348 | COLORADO MICRODISSECTION NEEDLE | Stryker Leibinger | 2000-05-03 | Traditional | PDF ↗ |
| K000778 | ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01 | Arthrocare Corp. | 2000-05-03 | Traditional | PDF ↗ |
| K000480 | ACTIVE ELECTRODE MONITORING SYSTEM | Electroscope, Inc. | 2000-05-02 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.