meddevicedb.com FDA Device Reference

Review Panel

General, Plastic Surgery FDA 510(k) Clearances & Devices

Cleared Devices
16,323
Product Codes (page)
30
Latest Decision
1997-09-19

Clearances · page 93 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K972415 MINISITE*BIPOLAR FORCEPS** DEVICE United States Surgical, A Division of Tyco Healthc GEI Class II 1997-09-19
K972311 MODEL 20 BIPOLAR COAGULATOR Boston Surgical Products, Inc. GEI Class II 1997-09-18
K971089 OPPORTUNITY, INC. LACERATION TRAY Opportunity, Inc. KKX Class II 1997-09-16
K972009 PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE Tillotson Healthcare Corp. KGO Class I 1997-09-12
K970817 MICROMARK CLIP Biopsys Medical, Inc. GDW Class II 1997-09-11
K972412 PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, Inc. FTL Class II 1997-09-10
K972227 SHOE COVER American Seal Co. FYF Class I 1997-09-09
K972187 BOUFFANT CAP American Seal Co. KKX Class II 1997-09-09
K972519 GRASPING FORCEPS, RIGHT AND LEFT CURVED Richard Wolf Medical Instruments Corp. GEI Class II 1997-09-08
K970808 MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASER Continuum Biomedical, Inc. GEX Class II 1997-09-05
K972441 RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000 Radiotherapeutics Corp. GEI Class II 1997-09-04
K972367 STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT Stryker Instruments KIJ Class I 1997-09-04
K970835 FACE MASK, SURGICAL MASK, NON-STERILE Tucker & Associates FXX Class II 1997-09-03
K960756 LIFETECH CASSETTE Lifetech Systems, Inc. KPJ Class II 1997-08-29
K972411 LINK CEMENT PLUG Turnkey Intergration USA, Inc. LZN Class II 1997-08-29
K964779 MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE Quantum Loop, Inc. GEI Class II 1997-08-27
K972497 KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES KARL STORZ Endoscopy-America, Inc. GEI Class II 1997-08-27
K972002 CYNOSURE DERMATOLOGY LASER COOLING TIP Cynosure, Inc. GEX Class II 1997-08-27
K972628 THERMOGARD & THERMOGARD PLUS ABC Conmedcorp GEI Class II 1997-08-27
K972299 BERGEN MODEL 500 ELECTROSURGERY GENERATOR Bergen Mfg. GEI Class II 1997-08-27
K965237 NURSES BOUFFANT CAP Copioumed Intl., Inc. LYU Class I 1997-08-27
K972099 SHARPLAN EPITOUCH RUBY LASER SYSTEM Sharplan Lasers, Inc. GEX Class II 1997-08-27
K972810 OPT80 THE TRANSPORTABLE (OPT80) O.P.T. USA, Inc. FQO Class I 1997-08-26
K972508 SURGICAL BURS AND SURGICAL DRILL BITS Synvasive Technology, Inc. HWE Class I 1997-08-26
K970891 DRAPE, SURGICAL-LATEX Protek Medical Products, Inc. KKX Class II 1997-08-22
K972646 AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES Ludlow Technical Products NAE Class I 1997-08-21
K972350 MODEL 50 BIPOLAR COAGULATOR Boston Surgical Products, Inc. GEI Class II 1997-08-21
K971509 ENDOXANE Novatech SA NWA Class II 1997-08-21
K971903 SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASER Continuum Biomedical, Inc. GEX Class II 1997-08-21
K971677 ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD Transamerican Technologies Intl. GEI Class II 1997-08-20
K972308 MEDNEXT 1000 DRILL Mednext, Inc. GEY Class I 1997-08-20
K971874 SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) Sharplan Lasers, Inc. GEX Class II 1997-08-18
K971540 AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORD American Biosurgical, Inc. GEI Class II 1997-08-14
K971879 SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER Continuum Biomedical, Inc. GEX Class II 1997-08-14
K964176 TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS Tecno Instruments (Usa), Inc. GEI Class II 1997-08-14
K971941 AQUA SPRAY Boyd Industries, Inc. GEY Class I 1997-08-14
K972566 DEXON VIOLET Davis & Geck, Inc. GAM Class II 1997-08-14
K971830 ACCU-PULSE CARBON DIOXIDE LASER SYSTEM Argus Photonics Group GEX Class II 1997-08-14
K965124 LASETTE Cell Robotics, Inc. GEX Class II 1997-08-14
K964831 SURESCAN Clinicon Corp. GEX Class II 1997-08-08
K971737 CYNOSURE PHOTOGENICA LPIR DERMATOLOGICAL LASER Cynosure, Inc. GEX Class II 1997-08-08
K971745 BARD COMPOSITE PROSTHESIS Davol Inc., Sub. C. R. Bard, Inc. FTL Class II 1997-08-06
K970561 GRAFT PATCH Organogenesis, Inc. FTL Class II 1997-08-01
K971814 IMPROVEMENTS TO THE MEHL RUBY LASER Mehl/Biophile Intl., Inc. GEX Class II 1997-08-01
K970793 IMPLANTABLE CLIP United States Surgical, A Division of Tyco Healthc FZP Class II 1997-07-30
K971597 COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) Coloplast Corp. NAE Class I 1997-07-29
K971782 BONE AND MARROW COLLECTION SYSTEM KIT Biomedical Ent., Inc. GEY Class I 1997-07-29
K971916 MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL Medical Z, S.A. MDA Class I 1997-07-29
K971009 SCAR CARE Target Health, Inc. MDA Class I 1997-07-29
K972272 LASER PERIPHERALS HOLMIUM BARE FIBERS Laser Peripherals, LLC GEX Class II 1997-07-29
K971744 FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503) Berkley Medical Resources, Inc. FXX Class II 1997-07-28
K963777 HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 Stephenson Industries, Inc. KPJ Class II 1997-07-28
K971843 LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES Laserscope GEX Class II 1997-07-23
K971532 ARTHROCARE ELECTROSURGERY SYSTEM Arthrocare Corp. GEI Class II 1997-07-23
K971648 SHARPLAN ERBIUM: YAG LASER (4020) Sharplan Lasers, Inc. GEX Class II 1997-07-23
K971758 CAUTERIZATION SMOKE EVACUATOR Applied Medical Technologies GEI Class II 1997-07-21
K971479 DURALASTIC ANATOMICAL MALAR IMPLANTS Allied Biomedical Corp. LZK Class II 1997-07-18
K971743 SHARPLAN CO2 SURGICAL LASER SYSTEM Sharplan Lasers, Inc. GEX Class II 1997-07-18
K971481 DURALASTIC ANATOMICAL NASAL IMPLANTS Allied Biomedical Corp. FZE Class II 1997-07-18
K971478 DURALASTIC ANATOMICAL CHIN IMPLANTS Allied Biomedical Corp. FWP Class II 1997-07-18
K971446 3M UNIVERSAL ELECTROSURGICAL PAD SPLIT/SOLID(9130&9160) 3M Company GEI Class II 1997-07-18
K971310 AESCULAP JET IRRIGATION SYSTEM Aesculap, Inc. GEI Class II 1997-07-18
K971459 DERMALASE Endo Technic Corp. GEX Class II 1997-07-18
K971450 SOMNOPLASTY SYSTEM Somnus Medical Technologies, Inc. GEI Class II 1997-07-17
K970160 UNIJECT SURGICAL GLOVES Uniject Gloves , Ltd. KGO Class I 1997-07-15
K971945 PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC SURGICAL GLOVE Tillotson Healthcare Corp. KGO Class I 1997-07-14
K965130 CHROMOPHARE Berchtold Holding GmbH FSY Class II 1997-07-14
K965128 CYNOSURE PHOTOGENICA VLV CUTANEOUS VASCULAR LESION LASER Cynosure, Inc. GEX Class II 1997-07-14
K962539 GANTEX MODEL NSG-75PF American Pro Latex, Inc. KGO Class I 1997-07-14
K971988 ALLEN, ULTRA AND SMART SOCKETS Allen Medical Systems, Inc. FQO Class I 1997-07-11
K970461 CELL ROBOTICS ER: YAG SURGICAL LASER Cell Robotics, Inc. GEX Class II 1997-07-11
K971191 FAR-EAST SHOE COVERS Far East Science & Technology Development Co., Ltd. FXP Class I 1997-07-10
K970988 FAR-EAST BOUFFANT CAPS Far East Science & Technology Development Co., Ltd. LYU Class I 1997-07-10
K971404 SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER Schwartz Electro-Optics, Inc. GEX Class II 1997-07-09
K972269 DISPOSABLE PATIENT RETURN ELECTRODE Erbe USA, Inc. GEI Class II 1997-07-09
K971381 POWDER-FREE DURAPRENE STERILE SYNTHETIC SURGICAL GLOVES Allegiance Healthcare Corp. KGO Class I 1997-07-09
K972273 TBD Megadyne Medical Products, Inc. GEI Class II 1997-07-08
K971702 FAR-EAST BARRIER GOWNS Far East Science & Technology Development Co., Ltd. FYC Class II 1997-07-08
K971342 DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) Disk Whisk, Inc. HWE Class I 1997-07-08
K970995 CMS CRYOLITE Cryomedical Sciences, Inc. GEH Class II 1997-07-07
K971473 IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK M-Pact Worldwide Management Corp. GEC Class I 1997-07-07
K963249 EPILIGHT HAIR REMOVAL SYSTEM Esc Medical Systems , Ltd. GEX Class II 1997-07-07
K971268 BONE & MARROW CLLECTION SYSTEM Biomedical International Corp. GEY Class I 1997-07-03
K971472 SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA Technical Products, Inc. FTL Class II 1997-07-01
K970338 TWEEZER-TYPE EPILATOR Igia Direct, Inc. KCX Class I 1997-07-01
K971250 LASERSCOPE MICROBEAM IV MICROMANIPULATOR Laserscope GEX Class II 1997-06-30
K971130 DEFEND FLUID RESISTANT PLEATED MASK Carl Parker Associates, Inc. FXX Class II 1997-06-27
K971307 AMSCO SURGICAL TABLE STERIS Corporation FQO Class I 1997-06-27
K971159 SURGICAL DRAPES International Medsurg Connection KKX Class II 1997-06-24
K971482 DEGANIA SILICONE SIL-K Degania Silicone , Ltd. MDA Class I 1997-06-24
K971711 SOMNUS MODEL 215 ELECTROSURGICAL GENERATOR Somnus Medical Technologies, Inc. GEI Class II 1997-06-24
K971193 LASEAWAY LONG PULSE AND Q-SWITCHED RUBY LASER SYSTEM Polytec Pi, Inc. GEX Class II 1997-06-24
K972072 SURGITRON MODEL FFPF-EMC Ellman Intl., Inc. GEI Class II 1997-06-19
K971978 GRAFT HARVESTING SAWBLADES Wrightmedicaltechnologyinc GFA Class I 1997-06-18
K970809 BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL Somnus Medical Technologies, Inc. GEI Class II 1997-06-18
K972161 BOVIE MODEL X15 Maxxim Medical GEI Class II 1997-06-18
K964818 ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION) Laserscope GEX Class II 1997-06-17
K971065 DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES Xintec Corporation GEX Class II 1997-06-17
K971024 SOFTSCAN Sahar Technologies, Inc. GEX Class II 1997-06-17
K970992 PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS Premier Dental Products Co. GEH Class II 1997-06-17

16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.