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 13 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K031079 | EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE | Gyrus Medical, Inc. | 2003-05-21 | Special | PDF ↗ |
| K031285 | MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD | Megadyne Medical Products, Inc. | 2003-05-19 | Traditional | PDF ↗ |
| K031078 | EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS | Gyrus Medical, Inc. | 2003-05-16 | Special | PDF ↗ |
| K031080 | EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS | Gyrus Medical, Inc. | 2003-05-16 | Special | PDF ↗ |
| K023733 | COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR | Ingenjorsfirman Bjorn Bergdahl AB | 2003-05-14 | Abbreviated | PDF ↗ |
| K031257 | RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR | Rita Medical Systems, Inc. | 2003-05-02 | Traditional | PDF ↗ |
| K030967 | RITA STARBURST SDE ELECTROSURGICAL DEVICE | Rita Medical Systems | 2003-04-21 | Special | PDF ↗ |
| K030954 | ARTHROCARE PERCD SPINEWAND | Arthrocare Corp. | 2003-04-16 | Special | PDF ↗ |
| K030362 | SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES | Leonhard Lang GmbH | 2003-04-14 | Abbreviated | PDF ↗ |
| K023311 | LOOP MICROWAVE ABLATION PROBE | Vivant Medical, Inc. | 2003-04-09 | Traditional | PDF ↗ |
| K030890 | SWITCHBLADE | Snowden Pencer, Inc. | 2003-04-04 | Traditional | PDF ↗ |
| K030697 | RADIONICS SINGLE USE GROUND PAD (DGP-HP) | Radionics, Inc. | 2003-04-04 | Special | PDF ↗ |
| K023288 | COBRA BIPOLAR CLAMP, MODEL 15902 | Boston Scientific EP Technologies | 2003-04-02 | Traditional | PDF ↗ |
| K023111 | GYRUS PLASMA SKIN RESURFACING SYSTEM | Gyrus Medical, Inc. | 2003-03-13 | Traditional | PDF ↗ |
| K024266 | MSI TA ELECTRODES | Medsphere International, Inc. | 2003-03-12 | Traditional | PDF ↗ |
| K024138 | HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE | Olympus Optical Co., Ltd. | 2003-03-12 | Traditional | PDF ↗ |
| K030557 | MODIFICATION TO VNUS CLOSURE SYSTEM | Vnus Medical Technologies, Inc. | 2003-03-11 | Special | PDF ↗ |
| K030339 | CAUTERY TIP CLEANER, MODEL-TC-100 | Aspen Surgical Products, Inc. | 2003-03-07 | Traditional | PDF ↗ |
| K030551 | ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE PATIENT CABLE; FOOT CONTROL; POWER CORD; WANDS | Arthrocare Corp. | 2003-03-07 | Special | PDF ↗ |
| K030380 | TISSUELINK SEALING FORCEPS, MODEL 1 21-202-1 | Tissuelink Medical, Inc. | 2003-03-03 | Special | PDF ↗ |
| K023966 | DISPOSABLE BI-POLAR CABLE | Modern Medical Equipment Mfg., Ltd. | 2003-02-27 | Traditional | PDF ↗ |
| K030473 | SENORX ES-300 | Senorx, Inc. | 2003-02-26 | Traditional | PDF ↗ |
| K024304 | MICROSURGICAL BIPOLAR HANDPIECE | Neomedix Corp. | 2003-02-25 | Traditional | PDF ↗ |
| K023924 | AUTOCON II 200 ELECTROSURGICAL GENERATOR | Karl Storz Endoscopy | 2003-02-21 | Traditional | PDF ↗ |
| K022532 | TISSUELINK BIPOLAR FLOATING BALL DEVICE | Tissuelink Medical, Inc. | 2003-02-12 | Traditional | PDF ↗ |
| K021852 | OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES | Olympus Optical Co., Ltd. | 2003-02-11 | Traditional | PDF ↗ |
| K022856 | BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR | Aaron Medical Industries | 2003-02-10 | Traditional | PDF ↗ |
| K030142 | THERMACOOL TC SYSTEM | Thermage, Inc. | 2003-02-03 | Special | PDF ↗ |
| K030108 | ARTHROCARE ENT COBLATOR SURGERY SYSTEM | Arthrocare Corp. | 2003-02-03 | Special | PDF ↗ |
| K030049 | MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086 | Rubicor Medical, Inc. | 2003-01-29 | Special | PDF ↗ |
| K023813 | BIPOLAR FORCEPS | Richard Wolf Medical Instruments Corp. | 2003-01-17 | Traditional | PDF ↗ |
| K030028 | CPC BY SORING GMBH | Soring GmbH Medizintechnik | 2003-01-17 | Special | PDF ↗ |
| K023482 | AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500 | Kirwan Surgical Products, Inc. | 2003-01-15 | Traditional | PDF ↗ |
| K024047 | ERBE VIO APC WITH ACCESSORIES | Erbe USA, Inc. | 2003-01-08 | Special | PDF ↗ |
| K024059 | MBC SERIES | Soring GmbH Medizintechnik | 2003-01-08 | Special | PDF ↗ |
| K023280 | OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES | Olympus Optical Co., Ltd. | 2002-12-19 | Traditional | PDF ↗ |
| K023986 | ARTHREX OPES ELECTRODES AND ACCESSORIES | Arthrex, Inc. | 2002-12-17 | Traditional | PDF ↗ |
| K023886 | ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D | Erbe USA, Inc. | 2002-12-12 | Special | PDF ↗ |
| K023846 | MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY | Rita Medical Systems | 2002-12-06 | Special | PDF ↗ |
| K023812 | NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20193-084 AND P/N: 20193-085 | Erbe USA, Inc. | 2002-11-29 | Special | PDF ↗ |
| K023767 | UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES | The Olympus Optical Co. | 2002-11-29 | Special | PDF ↗ |
| K023765 | STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2002-11-29 | Special | PDF ↗ |
| K023601 | RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086 | Rubicor Medical, Inc. | 2002-11-19 | Special | PDF ↗ |
| K023493 | PK ZIP WING CUTTING DISSECTOR | Gyrus Medical, Inc. | 2002-11-13 | Special | PDF ↗ |
| K023492 | EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS | Gyrus Medical, Inc. | 2002-11-13 | Special | PDF ↗ |
| K023413 | MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM | Neothermia Corp. | 2002-11-08 | Special | PDF ↗ |
| K021402 | THERMAGE THERMACOOL TC SYSTEM | Thermage, Inc. | 2002-11-05 | Traditional | PDF ↗ |
| K021467 | AUTOCON II 400 ELECTROSURGICAL GENERATOR | KARL STORZ Endoscopy-America, Inc. | 2002-11-04 | Traditional | PDF ↗ |
| K023291 | COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X | Boston Scientific Corp | 2002-10-17 | Special | PDF ↗ |
| K021329 | RITA SYSTEM | Rita Medical Systems | 2002-10-09 | Traditional | PDF ↗ |
| K020334 | INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC | Jac-Cell Medic Corporation | 2002-10-03 | Traditional | PDF ↗ |
| K022475 | MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS | Arthrocare Corp. | 2002-10-03 | Special | PDF ↗ |
| K021804 | PRECISION PLUS TUNA OFFICE SYSTEM; PRESISION TUNA OFFICE SYSTEM; PROVU TUNA SYSTEM | Medtronic Vascular | 2002-08-28 | Traditional | PDF ↗ |
| K022718 | VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002 | Guidant Corporation, Cardiac Surgery | 2002-08-28 | Traditional | PDF ↗ |
| K021777 | GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) | Gyrus Ent LLC | 2002-08-26 | Traditional | PDF ↗ |
| K022296 | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | Neothermia Corp. | 2002-07-30 | Special | PDF ↗ |
| K012018 | BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910 | Acmi Corporation | 2002-07-16 | Traditional | PDF ↗ |
| K020585 | ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT | Gyrus Medical, Inc. | 2002-07-13 | Traditional | PDF ↗ |
| K021817 | AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V | Aaron Medical Industries | 2002-07-11 | Traditional | PDF ↗ |
| K013873 | COBRA CARDIAC ELECTROSURGICAL SYSTEM | Boston Scientific Corp | 2002-07-11 | Traditional | PDF ↗ |
| K021079 | ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX | Conmedcorp | 2002-07-01 | Traditional | PDF ↗ |
| K011220 | LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE | Radiotherapeutics Corp. | 2002-07-01 | Traditional | PDF ↗ |
| K012669 | REPROCESSED ELECTROSURGICAL ELECTRODES | Surgical Instruments Service and Savings, Inc. | 2002-06-27 | Traditional | PDF ↗ |
| K021299 | CONMED HEATWAVE HAND-CONTROLLED ELETRODE | Conmedcorp | 2002-06-26 | Traditional | PDF ↗ |
| K021519 | ARTHROCARE CONTROLLER, AUTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS | Arthrocare Corp. | 2002-06-06 | Special | PDF ↗ |
| K020711 | WALLACH LOOP ELECTRODE | Wallach Surgical Devices, Inc. | 2002-06-03 | Traditional | PDF ↗ |
| K021364 | MODIFICATION TO ENTEC PLASMA WANDS | Arthrocare Corp. | 2002-05-30 | Special | PDF ↗ |
| K021577 | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | Neothermia Corp. | 2002-05-29 | Special | PDF ↗ |
| K020778 | GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 | Gyrus Ent LLC | 2002-05-28 | Traditional | PDF ↗ |
| K020574 | TISSUELINK BIPOLAR FLOATING BALL DEVICE | Tissuelink Medical, Inc. | 2002-05-20 | Traditional | PDF ↗ |
| K020579 | AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03 | Aaron Medical Industries | 2002-05-13 | Traditional | PDF ↗ |
| K021117 | TTI THERMOMED MODEL 1.8 INSTRUMENT | Thermosurgery Technologies, Inc. | 2002-05-02 | Special | PDF ↗ |
| K020408 | SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWER CORD, AND VISAGE WANDSFF | Arthrocare Corp. | 2002-05-02 | Traditional | PDF ↗ |
| K012279 | PATTON TRIPOL | Patton Medical Corp. | 2002-04-30 | Traditional | PDF ↗ |
| K020919 | ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002-04-19 | Special | PDF ↗ |
| K021077 | MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD | Megadyne Medical Products, Inc. | 2002-04-17 | Traditional | PDF ↗ |
| K021046 | COBRA COOLED SURGICAL PROBE, MODEL 1596X | Boston Scientific Corp | 2002-04-16 | Special | PDF ↗ |
| K020135 | CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-6120 | Conmedcorp | 2002-04-12 | Traditional | PDF ↗ |
| K020186 | CONMED SYSTEM 5000 ESU | Conmedcorp | 2002-04-12 | Traditional | PDF ↗ |
| K020832 | ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS | Arthrocare Corp. | 2002-04-09 | Special | PDF ↗ |
| K020047 | RUBICOR BREAST BIOPSY DEVICE | Rubicor Medical, Inc. | 2002-04-05 | Traditional | PDF ↗ |
| K020067 | GYRUS ENT SOMNOPLASTY GENERATOR | Gyrus Ent LLC | 2002-04-04 | Traditional | PDF ↗ |
| K013369 | RESECTION ABLATOR | Linvatec Corp. | 2002-04-04 | Traditional | PDF ↗ |
| K020622 | ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; AND WANDS | Arthrocare Corp. | 2002-03-28 | Special | PDF ↗ |
| K014290 | ENTEC PLASMA WANDS | Arthrocare Corp. | 2002-03-28 | Traditional | PDF ↗ |
| K020031 | EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 | Neothermia Corp. | 2002-03-27 | Traditional | PDF ↗ |
| K014260 | TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE | Tissuelink Medical, Inc. | 2002-03-27 | Traditional | PDF ↗ |
| K014251 | NTERO HOTROD SYSTEM | Ntero Surgical, Inc. | 2002-03-26 | Traditional | PDF ↗ |
| K014207 | REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083 | Aesculap, Inc. | 2002-03-21 | Traditional | PDF ↗ |
| K020557 | ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS | Arthrocare Corp. | 2002-03-21 | Special | PDF ↗ |
| K014216 | SECCA SYSTEM | Curon Medical, Inc. | 2002-03-21 | Traditional | PDF ↗ |
| K014172 | NELSON ELECTROSURGICAL UNIT, MODEL GN640 | Aesculap, Inc. | 2002-03-19 | Traditional | PDF ↗ |
| K013680 | CARBODISSECTING ENDOSCOPE | Endo Surgical Devices, Inc. | 2002-03-04 | Traditional | PDF ↗ |
| K014201 | AARON REUSABLE ELECTROSURGICAL ELECTRODE | Aaron Medical Industries | 2002-02-25 | Traditional | PDF ↗ |
| K013904 | BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230 | Baylis Medical Co., Inc. | 2002-02-12 | Traditional | PDF ↗ |
| K013730 | ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES | Novasys Medical, Inc. | 2002-02-06 | Traditional | PDF ↗ |
| K013668 | BERCHTOLD ELEKTROTOM 106 HITT | Berchtold Corp. | 2002-02-04 | Traditional | PDF ↗ |
| K012314 | DYONICS ELECTROBLADE RESECTOR | Smith & Nephew, Inc. | 2002-02-01 | Traditional | PDF ↗ |
| K013622 | NUCLEOTOMY INTRADISCAL CATHETER | Oratec Interventions, Inc. | 2002-01-31 | Traditional | PDF ↗ |
| K013641 | SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS | Senorx, Inc. | 2002-01-29 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.