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 16 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K982748 | BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224 | New Deantronics Taiwan , Ltd. | 1998-11-03 | Traditional | PDF ↗ |
| K982717 | SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 | Somnus Medical Technologies, Inc. | 1998-11-02 | Traditional | PDF ↗ |
| K982984 | ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS | Microline Pentax, Inc. | 1998-10-21 | Traditional | PDF ↗ |
| K981888 | SMOKE-EVAC | Bio-Medical Devices, Inc. | 1998-10-15 | Traditional | PDF ↗ |
| K974170 | DUOSTAR | Mti Corp./ Electrostar S.A.-Haiti | 1998-09-30 | Traditional | PDF ↗ |
| K982176 | KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR | Kirwan Surgical Products, Inc. | 1998-09-18 | Traditional | PDF ↗ |
| K982749 | MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-2 | New Deantronics Taiwan , Ltd. | 1998-09-14 | Traditional | PDF ↗ |
| K982746 | MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1 | New Deantronics Taiwan , Ltd. | 1998-09-14 | Traditional | PDF ↗ |
| K982884 | DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH TWO PIECE, SB 312RS, TWO DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH | New Deantronics, Ltd. | 1998-09-14 | Traditional | PDF ↗ |
| K982743 | DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBH | New Deantronics Taiwan , Ltd. | 1998-09-14 | Traditional | PDF ↗ |
| K981570 | AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1200 AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR MOD | Aaron Medical Industries | 1998-09-14 | Traditional | PDF ↗ |
| K982742 | DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH, ONE PIECE AND ONE PIECE HOLSTER MODELS SB 313 RS, SB 313 RSH | New Deantronics Taiwan , Ltd. | 1998-09-14 | Traditional | PDF ↗ |
| K982744 | DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT HOLSTER, MODELS SB 312PB, SB 312 PBH | New Deantronics Taiwan , Ltd. | 1998-09-11 | Traditional | PDF ↗ |
| K982705 | MIDAS TOUCH BIPOLAR FORCEPS | Iti Medical Technologies, Inc. | 1998-09-08 | Traditional | PDF ↗ |
| K981981 | ELECTROSURGICAL UNIT (ESU) (115 VOLT) MODEL 4810, ELECTROSURGICAL UNIT (ESU) (230 VOLT) MODEL 4811, INSTRUMENT CABLE, 19 | Boston Scientific Corp | 1998-09-03 | Traditional | PDF ↗ |
| K982677 | UNI/MONOPOLAR HF CABLE | Richard Wolf Medical Instruments Corp. | 1998-08-31 | Traditional | PDF ↗ |
| K981916 | LIGASURE VESSEL SEALING SYSTEM | Valleylab, Inc. | 1998-08-28 | Traditional | PDF ↗ |
| K981870 | VISAGE COSMETIC SURGERY SYSTEM | Arthrocare Corp. | 1998-08-20 | Traditional | PDF ↗ |
| K982130 | RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201 | New Deantronics, Ltd. | 1998-08-07 | Traditional | PDF ↗ |
| K981919 | BISSINGER CABLES, CAT. NO. 801000XX | Guenter Bissinger Medizintechnik GmbH | 1998-08-06 | Traditional | PDF ↗ |
| K981908 | UM-150A | Umeco Union Medical Engineering | 1998-08-05 | Traditional | PDF ↗ |
| K982309 | SMOKE EVACUATION ATTACHMENT 130XXX TBD | Conmedcorp | 1998-08-05 | Traditional | PDF ↗ |
| K981589 | ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELECTRODES | Conway Stuart Medical, Inc. | 1998-07-30 | Traditional | PDF ↗ |
| K981614 | NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/ HOLSTER, ES SMOKE & FLUID PENCIL W/ HOLSTER MODEL | Aaron Medical Industries | 1998-07-17 | Traditional | PDF ↗ |
| K981672 | RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR | Radiotherapeutics Corp. | 1998-07-17 | Traditional | PDF ↗ |
| K981361 | POWERSTAR BIPOLAR SCISSORS | ETHICON, Inc. | 1998-07-13 | Traditional | PDF ↗ |
| K981310 | MAGNATEK C-300 | Magna Advanced Technologies, Inc. | 1998-07-09 | Traditional | PDF ↗ |
| K981321 | BIPOLAR FORCEPS SET (MODULAR) | Richard Wolf Medical Instruments Corp. | 1998-07-07 | Traditional | PDF ↗ |
| K980177 | SUGITRON MODEL: IEC | Ellman Intl., Inc. | 1998-07-07 | Traditional | PDF ↗ |
| K980913 | CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 | Galil Medical , Ltd. | 1998-07-01 | Traditional | PDF ↗ |
| K980170 | SURGITRON | Ellman Intl., Inc. | 1998-06-29 | Traditional | PDF ↗ |
| K981219 | OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES | Enable Medical Corp. | 1998-06-29 | Traditional | PDF ↗ |
| K981416 | MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15 | Magna Advanced Technologies, Inc. | 1998-06-24 | Traditional | PDF ↗ |
| K981724 | O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100 | Medtrex, Inc. | 1998-06-22 | Traditional | PDF ↗ |
| K981430 | UNION MEDICAL UM-D30 COAGULATOR | She Medical, Inc. | 1998-06-05 | Traditional | PDF ↗ |
| K981389 | DISPOSABLE RE-NEW FORCEPS | Microline Pentax, Inc. | 1998-05-29 | Traditional | PDF ↗ |
| K981188 | ELECTROSURGICAL CAUTERY PROBES | Microline Pentax, Inc. | 1998-05-20 | Traditional | PDF ↗ |
| K980393 | SOPRANO CRYO-THERAPY SYSTEM | Gynecare Innovation Center | 1998-05-01 | Traditional | PDF ↗ |
| K981220 | SYSTEM 7500 ABC ELECTROSURGICAL UNIT | Aspen Laboratories, Inc. | 1998-04-21 | Traditional | PDF ↗ |
| K980758 | 3 MM SELEC-TIP LAPAROSCOPIC SCISSORS | Microline Pentax, Inc. | 1998-03-27 | Traditional | PDF ↗ |
| K974793 | ELMED ESU 120 M/M DIGITAL | Elmed, Inc. | 1998-03-19 | Traditional | PDF ↗ |
| K974464 | ORATEC SPINECATH INTRADISCAL CATHETER | Oratec Interventions, Inc. | 1998-03-19 | Traditional | PDF ↗ |
| K963965 | CTS MIDCAB STITCHER | Cardiothoracic Systems, Inc. | 1998-03-17 | Traditional | PDF ↗ |
| K980366 | AARON 1200 HIGH FREQUENCY ELECTROSURGICL GENERATOR A1200, A1200/240 | Aaron Medical Industries | 1998-02-27 | Traditional | PDF ↗ |
| K973197 | FIRE STICK | H.S. Intl. Co., Inc. | 1998-02-27 | Traditional | PDF ↗ |
| K980171 | DERMASENSE PLUS DISPERSIVE ELECTRODE | Horizon Medical, Inc. | 1998-02-27 | Traditional | PDF ↗ |
| K974521 | VNUS CLOSURE SYSTEM | Vnus Medical Technologies, Inc. | 1998-02-20 | Traditional | PDF ↗ |
| K974250 | VERSASTAT MULTIPOLAR SCISSORS AND CABLES | Pilling Weck, Inc. | 1998-02-11 | Traditional | PDF ↗ |
| K974484 | ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE | Ximed/Prosure/Injectx | 1998-02-10 | Traditional | PDF ↗ |
| K974553 | 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130) | 3M Healthcare | 1998-02-03 | Traditional | PDF ↗ |
| K974279 | 3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C) | 3M Healthcare | 1998-01-30 | Traditional | PDF ↗ |
| K973701 | SOMNUS TISSUE COAGULATING ELECTRODE | Somnus Medical Technologies, Inc. | 1998-01-30 | Traditional | PDF ↗ |
| K971829 | MIS ELECTROSURGICAL ELECTRODE | E-Tek, Inc. | 1998-01-28 | Traditional | PDF ↗ |
| K972358 | ORATEC MODEL ENDOTAC PROBE | Oratec Interventions, Inc. | 1998-01-23 | Traditional | PDF ↗ |
| K974066 | RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS | Microline Pentax, Inc. | 1998-01-22 | Traditional | PDF ↗ |
| K972562 | BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED | Electroscope, Inc. | 1998-01-16 | Traditional | PDF ↗ |
| K974022 | VAPR | Mitek Products | 1998-01-12 | Traditional | PDF ↗ |
| K970837 | SOMNUS MODEL 6000 DISPOSABLE TISSUE COAGULATING ELECTRODE | Somnus Medical Technologies, Inc. | 1998-01-09 | Traditional | PDF ↗ |
| K973478 | ARTHROCARE SINUS ELECTROSURGERY SYSTEM | Arthrocare Corp. | 1998-01-09 | Traditional | PDF ↗ |
| K970838 | SOMNUS MODEL 30XX DISPOSABLE TRI-NEEDLE COAGULATING ELECTRODE | Somnus Medical Technologies, Inc. | 1998-01-09 | Traditional | PDF ↗ |
| K973890 | UNIVERSALPLUS LAPAROSCOPIC ABC/ELECTROSURGICAL ELECTRODE | Conmedcorp | 1998-01-02 | Traditional | PDF ↗ |
| K973618 | SOMNOPLASTY SYSTEM | Somnus Medical Technologies, Inc. | 1997-12-19 | Traditional | PDF ↗ |
| K973682 | BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, | Electroscope, Inc. | 1997-12-18 | Traditional | PDF ↗ |
| K973648 | MINI FORCEPS WITH HF, 3.5MM; MICRO FORCEPS WITH HF, 2MM | Richard Wolf Medical Instruments Corp. | 1997-12-17 | Traditional | PDF ↗ |
| K973384 | ETHICON NON-STICK BIPOLAR FORCEPS | ETHICON, Inc. | 1997-12-05 | Traditional | PDF ↗ |
| K973295 | BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.451 | Richard Wolf Medical Instruments Corp. | 1997-11-26 | Traditional | PDF ↗ |
| K973190 | ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES | Cryomedical Sciences, Inc. | 1997-11-21 | Traditional | PDF ↗ |
| K972510 | PIVOTAL SCISSOR | Urohealth Systems, Inc. | 1997-11-13 | Traditional | PDF ↗ |
| K973341 | HOOK ELECTRODE, NEEDLE ELECTRODE, COAGULATION BUTTON ELECTRODE | Richard Wolf Medical Instruments Corp. | 1997-11-13 | Traditional | PDF ↗ |
| K973346 | UNCOATED ELECTROSURGICAL ELECTRODE | Megadyne Medical Products, Inc. | 1997-11-07 | Traditional | PDF ↗ |
| K973158 | ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE | Oratec Interventions, Inc. | 1997-11-05 | Traditional | PDF ↗ |
| K973297 | COSMAN COAGULATOR (CC-1) SYSTEM | Radionics, Inc. | 1997-10-29 | Traditional | PDF ↗ |
| K973173 | POWERSTAR BIPOLAR SCISSORS | ETHICON, Inc. | 1997-10-29 | Traditional | PDF ↗ |
| K973234 | MIDAS TOUCH ELECTROSURGICAL ELECTRODE | Iti Medical Technologies, Inc. | 1997-10-27 | Traditional | PDF ↗ |
| K972071 | BOVIE MODEL X40 | Maxxim Medical | 1997-10-21 | Traditional | PDF ↗ |
| K973110 | LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISPERSIVE ELECTRODES; WITH AND WITHOUT CORD | Ludlow Technical Products | 1997-10-21 | Traditional | PDF ↗ |
| K972558 | BIPOLAR SCISSORS | Enable Medical Corp. | 1997-10-07 | Traditional | PDF ↗ |
| K973159 | ORATEC INTERVENTIONS MODEL ORA 40 ELECTROTHERMAL GENERATOR | Oratec Interventions, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K972415 | MINISITE*BIPOLAR FORCEPS** DEVICE | United States Surgical, A Division of Tyco Healthc | 1997-09-19 | Traditional | PDF ↗ |
| K971728 | PIONEER ELEC-TROCAR DEVICE | Pioneer Surgical Technology | 1997-09-19 | Traditional | PDF ↗ |
| K972901 | AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD | American Biosurgical, Inc. | 1997-09-19 | Traditional | PDF ↗ |
| K972008 | ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS AND ELECTRODES | European Surgical, Inc. | 1997-09-19 | Traditional | PDF ↗ |
| K972311 | MODEL 20 BIPOLAR COAGULATOR | Boston Surgical Products, Inc. | 1997-09-18 | Traditional | PDF ↗ |
| K972519 | GRASPING FORCEPS, RIGHT AND LEFT CURVED | Richard Wolf Medical Instruments Corp. | 1997-09-08 | Traditional | PDF ↗ |
| K972441 | RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000 | Radiotherapeutics Corp. | 1997-09-04 | Traditional | PDF ↗ |
| K972299 | BERGEN MODEL 500 ELECTROSURGERY GENERATOR | Bergen Mfg. | 1997-08-27 | Traditional | PDF ↗ |
| K972628 | THERMOGARD & THERMOGARD PLUS ABC | Conmedcorp | 1997-08-27 | Traditional | PDF ↗ |
| K972497 | KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES | KARL STORZ Endoscopy-America, Inc. | 1997-08-27 | Traditional | PDF ↗ |
| K964779 | MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE | Quantum Loop, Inc. | 1997-08-27 | Traditional | PDF ↗ |
| K972350 | MODEL 50 BIPOLAR COAGULATOR | Boston Surgical Products, Inc. | 1997-08-21 | Traditional | PDF ↗ |
| K971677 | ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD | Transamerican Technologies Intl. | 1997-08-20 | Traditional | PDF ↗ |
| K971540 | AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORD | American Biosurgical, Inc. | 1997-08-14 | Traditional | PDF ↗ |
| K964176 | TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS | Tecno Instruments (Usa), Inc. | 1997-08-14 | Traditional | PDF ↗ |
| K971532 | ARTHROCARE ELECTROSURGERY SYSTEM | Arthrocare Corp. | 1997-07-23 | Traditional | PDF ↗ |
| K971758 | CAUTERIZATION SMOKE EVACUATOR | Applied Medical Technologies | 1997-07-21 | Traditional | PDF ↗ |
| K971446 | 3M UNIVERSAL ELECTROSURGICAL PAD SPLIT/SOLID(9130&9160) | 3M Company | 1997-07-18 | Traditional | PDF ↗ |
| K971310 | AESCULAP JET IRRIGATION SYSTEM | Aesculap, Inc. | 1997-07-18 | Traditional | PDF ↗ |
| K971450 | SOMNOPLASTY SYSTEM | Somnus Medical Technologies, Inc. | 1997-07-17 | Traditional | PDF ↗ |
| K972269 | DISPOSABLE PATIENT RETURN ELECTRODE | Erbe USA, Inc. | 1997-07-09 | Traditional | PDF ↗ |
| K972273 | TBD | Megadyne Medical Products, Inc. | 1997-07-08 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.