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 11 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K070101 | UNIBLATE ELECTROSURGICAL DEVICE | Rita Medical Systems, Inc. | 2007-02-14 | Traditional | PDF ↗ |
| K063748 | THERMOMED 1.8 | Thermosurgery Technologies, Inc. | 2007-02-01 | Traditional | PDF ↗ |
| K070165 | ENSEAL PTC TRIO | Surgrx, Inc. | 2007-01-29 | Special | PDF ↗ |
| K063630 | ATRICURE ABLATION SYSTEM | AtriCure, Inc. | 2007-01-26 | Traditional | PDF ↗ |
| K062712 | ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094 | Erbe USA, Inc. | 2007-01-26 | Traditional | PDF ↗ |
| K062082 | CONMED ABC DISSECTING BLADE ELECTRODE, MODEL 139330; BLUNT NEEDLE ELECTRODE, MODEL 139331 | Conmed Corporation | 2007-01-25 | Traditional | PDF ↗ |
| K063485 | LOGIC LAPAROSCOPIC SCISSORS | Surgical Innovations Plc | 2006-12-01 | Traditional | PDF ↗ |
| K063025 | LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420, | Lina Medical Aps | 2006-12-01 | Traditional | PDF ↗ |
| K062539 | NCONTACT COAGULATION SYSTEM KIT | Ncontact Surgical, Inc. | 2006-12-01 | Traditional | PDF ↗ |
| K063538 | ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD AND WANDS | Arthrocare Corp. | 2006-12-01 | Special | PDF ↗ |
| K063195 | LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS LF5034 AND LF5044 | Valleylab | 2006-11-29 | Traditional | PDF ↗ |
| K063161 | SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL | Leonhard Lang GmbH | 2006-11-21 | Special | PDF ↗ |
| K061829 | ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES | New Leaf Medical, Inc. | 2006-11-17 | Traditional | PDF ↗ |
| K062441 | BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020 | Barrx Medical, Incorporated | 2006-11-14 | Traditional | PDF ↗ |
| K062723 | HALO90 COAGULATION CATHETER | Barrx Medical, Incorporated | 2006-11-09 | Special | PDF ↗ |
| K061878 | ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC | E Surgical, LLC | 2006-10-24 | Traditional | PDF ↗ |
| K063097 | ENSEAL PTC TISSUE SEALING DEVICE | Surgrx, Inc. | 2006-10-18 | Special | PDF ↗ |
| K062949 | ENSEAL PTC TISSUE SEATING SEALING DEVICE | Surgrx, Inc. | 2006-10-18 | Special | PDF ↗ |
| K052907 | POLARCOAT | Patton Surgical Corp. | 2006-10-16 | Traditional | PDF ↗ |
| K062935 | HABIB 4X LAPAROSCOPIC | Rita Medical Systems | 2006-10-13 | Traditional | PDF ↗ |
| K061544 | STELLARTECH 100 COAGULATION SYSTEM | Stellartech Research Corp. | 2006-10-13 | Traditional | PDF ↗ |
| K061001 | THERMASSAGE | Thermage, Inc. | 2006-10-12 | Traditional | PDF ↗ |
| K061417 | GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 | Genicon | 2006-10-10 | Traditional | PDF ↗ |
| K062257 | STARION INSTRUMENTS THERMAL LITIGATING SHEARS | Starion Instruments | 2006-10-10 | Special | PDF ↗ |
| K061660 | STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE | Stryker Instruments | 2006-10-10 | Traditional | PDF ↗ |
| K062337 | MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR | Aaron Medical Industries | 2006-10-05 | Traditional | PDF ↗ |
| K062047 | ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RETRACTABLE ELECTRODES | PAJUNK GmbH Medizintechnologie | 2006-10-05 | Special | PDF ↗ |
| K062072 | PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES | PAJUNK GmbH Medizintechnologie | 2006-09-22 | Special | PDF ↗ |
| K061225 | STRYKER DISPOSABLE LAPAROSCOPIC SCISSORS | Stryker Corp. | 2006-09-14 | Traditional | PDF ↗ |
| K061835 | STRYKER SILVERGLIDE BIPOLAR FORCEPS REUSABLE CABLE; DISPOSABLE CABLE | Stryker Instruments | 2006-09-08 | Traditional | PDF ↗ |
| K061884 | BOVIE ICON GI ELECTROSURGICAL GENERATOR, MODEL GI 120 | Bovie Medical | 2006-09-06 | Traditional | PDF ↗ |
| K060948 | PORTRAIT PSR3 | Rhytec Incorporated | 2006-09-05 | Traditional | PDF ↗ |
| K061635 | MSD BIPOLAR FORCEPS | Medtronic Sofamor Danek | 2006-09-05 | Traditional | PDF ↗ |
| K062225 | HALO COAGULATION CATHETER | Barrx Medical, Incorporated | 2006-08-28 | Special | PDF ↗ |
| K061425 | PUREWRIST SCISSORS, MODEL PW1101-01;PUREWRIST DISSECTOR, MODEL PW1201-01;PUREWRIST HOOK, MODEL PW1301-01 | Cambridge Endoscopic Devices | 2006-08-10 | Traditional | PDF ↗ |
| K061975 | PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK | Acmi Corporation | 2006-08-10 | Special | PDF ↗ |
| K061373 | VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100 | Vnus Medical Technologies, Inc. | 2006-08-01 | Traditional | PDF ↗ |
| K061307 | BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK | Aaron Medical Industries | 2006-07-18 | Traditional | PDF ↗ |
| K060232 | TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES | Trokamed GmbH | 2006-07-12 | Traditional | PDF ↗ |
| K061174 | SURGI-MAX | Ellman Int'L, Inc. | 2006-06-28 | Traditional | PDF ↗ |
| K061526 | ENSEAL PTC TISSUE SEALING DEVICE | Surgrx, Inc. | 2006-06-15 | Special | PDF ↗ |
| K052759 | DAN MONOPOLAR LAP ACCESSORIES | Dannoritzer Medizintechnik GmbH & Co. KG | 2006-06-14 | Traditional | PDF ↗ |
| K061258 | TRABECTOME HIGH FREQUENCY GENERATOR/LP | Neomedix Corp. | 2006-05-18 | Traditional | PDF ↗ |
| K061259 | MODIFICATION TO ARTHROCARE PERC-D SPINEWAND | Arthrocare Corp. | 2006-05-18 | Special | PDF ↗ |
| K060169 | BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520F | Barrx Medical, Incorporated | 2006-04-21 | Traditional | PDF ↗ |
| K060823 | ARTHROCARE WANDS | Arthrocare Corp. | 2006-04-10 | Special | PDF ↗ |
| K060255 | E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND ELECTROSURGICAL PATIENT RETURN ELECTRODE | E Surgical, LLC | 2006-03-31 | Traditional | PDF ↗ |
| K052297 | POREX ELECTROSURGERY NEEDLE | Porex Surgical, Inc. | 2006-03-28 | Traditional | PDF ↗ |
| K053510 | IR WIRELESS FOOT SWITCH | Linemaster Switch Corp. | 2006-03-20 | Traditional | PDF ↗ |
| K060484 | ERBE VIO ESU, MODEL VIO 300 D | Erbe USA, Inc. | 2006-03-16 | Special | PDF ↗ |
| K053290 | COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES | Valleylab | 2006-03-15 | Traditional | PDF ↗ |
| K060419 | CONCERTO BIPOLAR NEEDLE ELECTRODE | Boston Scientific Corp | 2006-03-13 | Special | PDF ↗ |
| K060400 | CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT | Medtronic, Inc. | 2006-02-28 | Traditional | PDF ↗ |
| K060117 | BOVIE BUTTON REMOTE HAND SWITCH | Aaron Medical Industries | 2006-02-22 | Traditional | PDF ↗ |
| K060183 | ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTER PROBE ADAPTER | Erbe USA, Inc. | 2006-02-16 | Special | PDF ↗ |
| K060170 | ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS | Erbe USA, Inc. | 2006-02-16 | Special | PDF ↗ |
| K052796 | COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES | Valleylab | 2006-02-03 | Traditional | PDF ↗ |
| K053433 | CAUTERY TIP CLEANER, MODEL 30500 | Xodus Medical, Inc. | 2006-01-19 | Traditional | PDF ↗ |
| K053326 | ESTECH COBRA ELECTROSURGICAL UNIT & CABLE | Endoscopic Technologies, Inc. | 2006-01-06 | Traditional | PDF ↗ |
| K053447 | ARTHROCARE PERC-D SPINEWAND | Arthrocare Corp. | 2005-12-27 | Special | PDF ↗ |
| K053100 | ESTECH COBRA BIPOLAR SYSTEM | Endoscopic Technologies, Inc. | 2005-12-19 | Traditional | PDF ↗ |
| K053365 | MODIFICATION TO THERMAGE THERMACOOL SYSTEM | Thermage, Inc. | 2005-12-13 | Traditional | PDF ↗ |
| K053282 | ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP | Pajunk GmbH | 2005-12-13 | Special | PDF ↗ |
| K053297 | ARTHROCARE 8000S COBLATOR SURGERY SYSTEM | Arthrocare Corp. | 2005-12-06 | Special | PDF ↗ |
| K053128 | SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE | Boston Scientific Corp | 2005-11-30 | Special | PDF ↗ |
| K052702 | MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY | Misonix, Inc. | 2005-11-21 | Traditional | PDF ↗ |
| K050550 | GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR | Gyrus Medical, Inc. | 2005-11-09 | Traditional | PDF ↗ |
| K052893 | ATRICURE TRANSPOLAR SYSTEM | AtriCure, Inc. | 2005-10-25 | Traditional | PDF ↗ |
| K052859 | AQUAMANTYS PUMP GENERATOR SYSTEM | Tissuelink Medical, Inc. | 2005-10-25 | Special | PDF ↗ |
| K050460 | GYRUS PLASMACISION AND PLASMABLEND ELECTRODES | Gyrus Medical, Inc. | 2005-10-25 | Traditional | PDF ↗ |
| K051214 | ALUMA SKIN RENEWAL SYSTEM | Lumenis, Inc. | 2005-10-24 | Traditional | PDF ↗ |
| K052104 | ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185; ULTRACLEAN FOOTCONTROLLED SUCTION | Conmed Corporation | 2005-10-21 | Traditional | PDF ↗ |
| K052857 | ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000 | Senorx, Inc. | 2005-10-21 | Special | PDF ↗ |
| K052778 | THERMAGE THERMACOOL SKIN MARKETING | Thermage, Inc. | 2005-10-20 | Traditional | PDF ↗ |
| K052203 | AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 | Kirwan Surgical Products, Inc. | 2005-10-20 | Traditional | PDF ↗ |
| K052449 | CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189 | Codman & Shurtleff, Inc. | 2005-10-17 | Traditional | PDF ↗ |
| K052003 | VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40) | Vnus Medical Technologies, Inc. | 2005-10-11 | Traditional | PDF ↗ |
| K052141 | STRYKER STILETTO ELECTROSURGICAL PROBE | Stryker Endoscopy | 2005-10-06 | Traditional | PDF ↗ |
| K052506 | RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108 | Rubicor Medical, Inc. | 2005-10-06 | Special | PDF ↗ |
| K052686 | ARTHROCARE ARTHROWANDS | Arthrocare Corp. | 2005-10-05 | Special | PDF ↗ |
| K052009 | CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR | Conmed Corporation | 2005-09-28 | Traditional | PDF ↗ |
| K052274 | GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000 | Guidant Corporation | 2005-09-21 | Special | PDF ↗ |
| K051749 | COBRA SURGICAL SYSTEM | Estech, Inc. | 2005-09-13 | Traditional | PDF ↗ |
| K051956 | DR. OPPEL ST-501 | Sometech Incorporated | 2005-09-08 | Traditional | PDF ↗ |
| K051831 | GEMINI SURGICAL CONTROL & DISPLAY SYSTEM | Applied Surgical, LLC | 2005-09-07 | Traditional | PDF ↗ |
| K052035 | CANADY PLASMA PROBES | Canady Technology, LLC | 2005-08-31 | Traditional | PDF ↗ |
| K052246 | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | Neothermia Corporation | 2005-08-22 | Traditional | PDF ↗ |
| K051420 | HABIB 4X | Emcision , Ltd. | 2005-08-15 | Traditional | PDF ↗ |
| K051644 | VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR | Valleylab | 2005-08-11 | Traditional | PDF ↗ |
| K051429 | CLARIS NON-STICK BIPOLAR FORCEPS | Guenter Bissinger Medizintechnik GmbH | 2005-07-29 | Traditional | PDF ↗ |
| K051627 | VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT | Valleylab | 2005-07-22 | Traditional | PDF ↗ |
| K051710 | THERMAGE THERMACOOL COUPLING FLUID | Thermage, Inc. | 2005-07-19 | Traditional | PDF ↗ |
| K051168 | BARRX HALO 360 SYSTEM, MODEL 1100C-115A | Barrx Medical, Incorporated | 2005-06-29 | Traditional | PDF ↗ |
| K050898 | SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX | Smith & Nephew, Inc. | 2005-05-25 | Traditional | PDF ↗ |
| K043036 | NON-STICK ELECTRODE | Modern Medical Equipment Mfg., Ltd. | 2005-05-06 | Traditional | PDF ↗ |
| K050831 | STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A | Stellartech Research Corp. | 2005-04-12 | Special | PDF ↗ |
| K042710 | SURGITRON RADIOLASE II | Ellman Int'L, Inc. | 2005-04-07 | Traditional | PDF ↗ |
| K050671 | ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM | Surgrx, Inc. | 2005-04-01 | Special | PDF ↗ |
| K050737 | NEOTHERMIA EN-BLOC BIOPSY SYSTEM | Neothermia Corporation | 2005-03-31 | Special | PDF ↗ |
| K050579 | MEGA POWER ELECTROSURGICAL GENERATOR | Megadyne Medical Products, Inc. | 2005-03-24 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.