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 10 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K083306 | MODIFICATION TO ARTHROCARE ARTHROWANDS | Arthrocare Corp. | 2008-12-10 | Special | PDF ↗ |
| K083013 | PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 | Gyrus Acmi, Inc. | 2008-12-09 | Traditional | PDF ↗ |
| K082962 | TIVAMED COOLED RF SYSTEM, MODEL 78001 | Tivamed, Inc. | 2008-12-04 | Traditional | PDF ↗ |
| K082786 | PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES | Peak Surgical, Inc. | 2008-12-03 | Traditional | PDF ↗ |
| K082568 | SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE | Bovie Medical | 2008-11-17 | Traditional | PDF ↗ |
| K082980 | ARTHROCARE ARTHROWANDS | Arthrocare Corp. | 2008-11-05 | Special | PDF ↗ |
| K081312 | ARAGON ONESHOT SYSTEM | Aragon Surgical, Inc. | 2008-10-31 | Traditional | PDF ↗ |
| K081791 | E-Z CLEAN ELECTROSURGICAL ELECTRODE | Megadyne Medical Products, Inc. | 2008-10-21 | Traditional | PDF ↗ |
| K082954 | ENCAGE BIPOLAR RF PROBE | Trod Medical SA | 2008-10-17 | Traditional | PDF ↗ |
| K082890 | VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2 | Vnus Medical Technologies, Inc. | 2008-10-15 | Special | PDF ↗ |
| K082666 | ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS | Arthrocare Corp. | 2008-10-15 | Special | PDF ↗ |
| K082202 | HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B | Barrx Medical, Incorporated | 2008-10-08 | Special | PDF ↗ |
| K082109 | BOVIE ICON GENERAL PURPOSE RF GENERATOR | Bovie Medical | 2008-10-02 | Traditional | PDF ↗ |
| K081553 | AED BIPOLAR FORCEPS, MODEL 13-1646 | National Advanced Endoscopy Devices, Inc. | 2008-09-29 | Traditional | PDF ↗ |
| K081503 | AED MONOPOLAR LAP ACCESSORIES | National Advanced Endoscopy Devices, Inc. | 2008-09-25 | Traditional | PDF ↗ |
| K073498 | LAPAROSCOPIC AND ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES, LAPAROSCOPY RUDOLF SYSTEM | Rudolf Medical GmbH + Co. KG | 2008-09-19 | Traditional | PDF ↗ |
| K081644 | BEAMER ARGON PROBE | Conmed Corporation | 2008-09-10 | Traditional | PDF ↗ |
| K082323 | ARTHROCARE ARTHROWANDS | Arthrocare Corp. | 2008-08-28 | Special | PDF ↗ |
| K081559 | GENESIS | Medisiss | 2008-08-28 | Traditional | PDF ↗ |
| K082197 | RHYTEC, INC., PORTRAIT PSR | Rhytec Incorporated | 2008-08-22 | Special | PDF ↗ |
| K081647 | ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS | Xodus Medical, Inc. | 2008-08-12 | Traditional | PDF ↗ |
| K081766 | PKS OMNI INSTRUMENT | Gyrus-Acmi L.P. | 2008-08-08 | Traditional | PDF ↗ |
| K082054 | GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003 | Gyrus Acmi, Inc. | 2008-08-06 | Special | PDF ↗ |
| K081954 | GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE | Gyrus Acmi, Inc. | 2008-07-31 | Special | PDF ↗ |
| K071759 | LTC VAD SYSTEM, MODELS #VAD.400 (ELECTROSURGICAL GENERATOR); PCS-900 AND PCC-900 (HAND PIECE INSTRUMENTS) | Live Tissue Connect, Inc. | 2008-07-30 | Traditional | PDF ↗ |
| K081678 | CONMED BEAMER SYSTEM C600 | Kls Martin GmbH + Co. KG | 2008-07-29 | Abbreviated | PDF ↗ |
| K081129 | ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL | Surgrx, Inc. | 2008-07-28 | Traditional | PDF ↗ |
| K081431 | MEG LAPAROSCOPIC ELECTRODES | Bovie Medical | 2008-07-24 | Traditional | PDF ↗ |
| K073616 | FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE | Electromedics Co. , Ltd. | 2008-07-23 | Traditional | PDF ↗ |
| K073057 | PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040 | Peak Surgical, Inc. | 2008-07-22 | Traditional | PDF ↗ |
| K080287 | ONCOBIONIC BIPOLAR ELECTRODE | AngioDynamics, Inc. | 2008-07-03 | Traditional | PDF ↗ |
| K080451 | UNIBLATE ELECTROSURGICAL DEVICE | AngioDynamics, Inc. | 2008-07-03 | Traditional | PDF ↗ |
| K081634 | CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL | Conmed Corporation | 2008-06-25 | Traditional | PDF ↗ |
| K080197 | PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM | Plasma Surgical, Ltd. | 2008-06-24 | Traditional | PDF ↗ |
| K081580 | BEAMER ARGON SNARE PROBE | Conmed Corporation | 2008-06-19 | Traditional | PDF ↗ |
| K080187 | OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS | Olsen Medical | 2008-05-09 | Traditional | PDF ↗ |
| K073207 | OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167 | Celon AG Medical Instruments | 2008-05-08 | Traditional | PDF ↗ |
| K080093 | PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK | Gyrus Acmi, Inc. | 2008-05-02 | Traditional | PDF ↗ |
| K072041 | BOVIE IDS-400 ELECTROSURGICAL GENERATOR | Bovie Medical | 2008-04-10 | Traditional | PDF ↗ |
| K080557 | BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS | Barrx Medical, Incorporated | 2008-04-02 | Special | PDF ↗ |
| K080715 | ERBE VIO ESU, MODEL VIO 200 S | Erbe USA, Inc. | 2008-04-02 | Special | PDF ↗ |
| K080610 | ARTHROCARE ORTHOWAND SURGICAL DEVICE | Arthrocare Corp. | 2008-03-31 | Special | PDF ↗ |
| K080717 | HABIB HEXABLATE 10 | Emcision , Ltd. | 2008-03-27 | Traditional | PDF ↗ |
| K073111 | PORTRAIT PSR, MODEL 745915 | Rhytec Incorporated | 2008-03-27 | Traditional | PDF ↗ |
| K073455 | E-VAC | New Leaf Medical, Inc. | 2008-03-25 | Special | PDF ↗ |
| K080482 | ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01 | Arthrocare Corp. | 2008-03-20 | Special | PDF ↗ |
| K073450 | SUTTER ELECTROSURGICAL CABLES | Sutter Medizintechnik GmbH | 2008-03-17 | Traditional | PDF ↗ |
| K080145 | PRIMAEVA MEDICAL SYSTEM | Primaeva Medical, Inc. | 2008-02-28 | Special | PDF ↗ |
| K071343 | ELLMAN NOBLE ALLOY ELECTRODES | Ellman International, Inc. | 2008-02-28 | Traditional | PDF ↗ |
| K073046 | ETHICON ENDO SURGERY ARTICULATING NEEDLE KNIFE, MODEL 2504 | Ethicon Endo-Surgery, Inc. | 2008-02-25 | Traditional | PDF ↗ |
| K073466 | SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM | Smith & Nephew, Inc. | 2008-02-22 | Traditional | PDF ↗ |
| K080282 | ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00; | Arthrocare Corp. | 2008-02-15 | Special | PDF ↗ |
| K072124 | BLACK AND BLACK ELECTROSURGICAL CUTTING AND COAGULATION FORCEPS AND ELECTRODES | Black & Black Surgical, Inc. | 2008-01-18 | Traditional | PDF ↗ |
| K072849 | MODIFICATION TO THERMAGE THERMACOOL SYSTEM | Thermage, Inc. | 2008-01-18 | Traditional | PDF ↗ |
| K073495 | TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT | Tissuelink Medical, Inc. | 2008-01-09 | Special | PDF ↗ |
| K073687 | HABIB LAPAROSCOPIC HEXABLATE | Emcision , Ltd. | 2008-01-09 | Traditional | PDF ↗ |
| K072937 | OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET | Olsen Medical | 2007-12-28 | Traditional | PDF ↗ |
| K072261 | FINESSE SYSTEM | Primaeva Medical, Inc. | 2007-12-26 | Traditional | PDF ↗ |
| K072478 | BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD | Baylis Medical Co., Inc. | 2007-12-19 | Special | PDF ↗ |
| K073360 | PROPLATE | Bio Protech, Inc. | 2007-12-19 | Traditional | PDF ↗ |
| K072911 | ION MEDICAL BIPOLAR COAGULATION PEN | Ion Medical, LLC | 2007-12-13 | Traditional | PDF ↗ |
| K072865 | MODIFICATON TO: ARTHROCARE ARTHROWANDS | Arthrocare Corp. | 2007-10-23 | Special | PDF ↗ |
| K072789 | DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES | Encision, Inc. | 2007-10-19 | Traditional | PDF ↗ |
| K070443 | INTRACEPT BI-POLAR RF PROBE, MODEL 04814 | Relievant Medsystems, Inc. | 2007-10-05 | Traditional | PDF ↗ |
| K072559 | SUCTION COAGULATOR | Megadyne Medical Products, Inc. | 2007-10-05 | Traditional | PDF ↗ |
| K072699 | ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XL | Alma Lasers , Ltd. | 2007-10-05 | Special | PDF ↗ |
| K072126 | HABIB VESEAL | Emcision , Ltd. | 2007-10-02 | Traditional | PDF ↗ |
| K072493 | ENSEAL TISSUE SEALING DEVICE | Surgrx, Inc. | 2007-09-27 | Special | PDF ↗ |
| K071859 | STRYKER CROSSFIRE SYSTEM | Stryker Endoscopy | 2007-09-20 | Traditional | PDF ↗ |
| K070812 | DISPOSABLE LAPAROSCOPIC INSTRUMENT | Modern Medical Equipment Mfg., Ltd. | 2007-09-14 | Special | PDF ↗ |
| K072394 | PORTRAIT STAND-OFF | Rhytec Incorporated | 2007-09-12 | Special | PDF ↗ |
| K071976 | VECTEC DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES | Vectec | 2007-09-06 | Traditional | PDF ↗ |
| K072177 | ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM | Surgrx, Inc. | 2007-09-05 | Special | PDF ↗ |
| K071080 | ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M | E Surgical, LLC | 2007-08-31 | Traditional | PDF ↗ |
| K072089 | ARTHROCARE SPINEWAND | Arthrocare Corp. | 2007-08-17 | Special | PDF ↗ |
| K071963 | MODIFICATION TO: ARTHROCARE ARTHROWANDS | Arthrocare Corp. | 2007-08-07 | Special | PDF ↗ |
| K071709 | ARTHROCARE SYSTEM 12000 | Arthrocare Corp. | 2007-08-07 | Traditional | PDF ↗ |
| K071786 | PORTRAIT PSR | Rhytec Incorporated | 2007-07-26 | Special | PDF ↗ |
| K071728 | MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE | Surgrx, Inc. | 2007-07-13 | Special | PDF ↗ |
| K071543 | HALO360' COAGULATION CATHETER | Barrx Medical, Incorporated | 2007-06-29 | Special | PDF ↗ |
| K071103 | HABIB HEXABLATE | Emcision , Ltd. | 2007-06-27 | Traditional | PDF ↗ |
| K052936 | THERMAGE THERMACOOL SYSTEM | Thermage, Inc. | 2007-06-12 | Traditional | PDF ↗ |
| K062171 | EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES | Ortho Development Corp. | 2007-05-25 | Traditional | PDF ↗ |
| K063480 | STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750 | Stryker Corp. | 2007-05-22 | Traditional | PDF ↗ |
| K070997 | DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX | Pro-Med Instruments GmbH | 2007-05-16 | Traditional | PDF ↗ |
| K062525 | REPROCESSED LIGASURE VESSEL SEALER/DIVIDER | Ascent Healthcare Solutions | 2007-05-16 | Traditional | PDF ↗ |
| K070446 | COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL | Valleylab,A Division of Tyco Healthcare Group LP | 2007-05-02 | Traditional | PDF ↗ |
| K063172 | ARTHROCARE CAVITY SPINEWAND | Arthrocare Corp. | 2007-04-27 | Traditional | PDF ↗ |
| K070374 | ARTHROCARE ENT PLASMA WAND | Arthrocare Corp. | 2007-04-25 | Traditional | PDF ↗ |
| K070311 | CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261 | Medtronic Vascular | 2007-04-24 | Traditional | PDF ↗ |
| K070711 | INCIRCLE BI-POLAR RF ABLATION SYSTEM | Rfa Medical, Inc. | 2007-04-24 | Traditional | PDF ↗ |
| K070896 | ENSEAL PTC TISSUE SEALING DEVICE | Surgrx, Inc. | 2007-04-24 | Special | PDF ↗ |
| K070004 | ACCENT | Alma Lasers , Ltd. | 2007-04-23 | Traditional | PDF ↗ |
| K070958 | MODIFICATION TO ARTHROCARE ARTHROWANDS | Arthrocare Corp. | 2007-04-23 | Special | PDF ↗ |
| K070851 | ARTHROCARE SPINEWANDS | Arthrocare Corp. | 2007-04-13 | Special | PDF ↗ |
| K070275 | FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE | Rubicor Medical, Inc. | 2007-03-09 | Traditional | PDF ↗ |
| K070162 | FORCETRIAD ELECTROSURGICAL GENERATOR; LIGASURE INSTRUMENTS | Valleylab,A Division of Tyco Healthcare Group LP | 2007-03-06 | Traditional | PDF ↗ |
| K062350 | SURGINETICS ADVANTAGEBLADE | Surginetics | 2007-02-26 | Traditional | PDF ↗ |
| K063639 | AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1 | Tissuelink Medical, Inc. | 2007-02-22 | Traditional | PDF ↗ |
| K062464 | MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR | KARL STORZ Endoscopy-America, Inc. | 2007-02-16 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.