meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
26
Latest Decision
2000-04-27

Clearances · page 85 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K000540 POLYESTER NONABSORBABLE SURGICAL SUTURES, USP Arc Medical Supplies (Beijing) Co, Ltd. GAT Class II 2000-04-27
K000496 EVERSHEARS BIPOLAR SCISSORS Everest Medical Corp. GEI Class II 2000-04-24
K992597 LORAD LT-100 LASER TREATMENT SYSTEM Focus Medical, LLC GEX Class II 2000-04-24
K001189 MODIFICATION TO CONVERTORS SURGICAL GOWNS Allegiance Healthcare Corp. FYA Class II 2000-04-21
K000936 VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM Mitek Products GEI Class II 2000-04-19
K000222 UM-L25 Union Medical Engeneering Co., Ltd. GEX Class II 2000-04-19
K000961 AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE Aaron Medical Industries GEI Class II 2000-04-19
K000245 CSM STRETTA SYSTEM Conway Stuart Medical, Inc. GEI Class II 2000-04-18
K000106 DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES Fotona D.D. GEX Class II 2000-04-18
K990034 WILSON-COOK COLONIC Z-STENT Med Institute, Inc. MQR Class II 2000-04-17
K000911 MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057 Hysterx, Inc. GEI Class II 2000-04-14
K000971 PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE Wrp Asia Pacific Sdn. Bhd. KGO Class I 2000-04-14
K000241 RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR Radiotherapeutics Corp. GEI Class II 2000-04-14
K993695 LIGA-LOOP SUTURE APPLICATOR Hysterx, Inc. GAL Class II 2000-04-13
K000192 E3 MICROPROB SERIES OF LASERS AND ACCESSORIES Martin Uram, MD GEX Class II 2000-04-10
K982556 LEVEEN NEEDLE ELECTRODE Radiotherapeutics Corp. GEI Class II 2000-04-06
K993412 BITX PROBES Everest Medical Corp. GEI Class II 2000-03-31
K000032 LEVEEN NEEDLE ELECTRODE Radiotherapeutics Corp. GEI Class II 2000-03-30
K000037 MONOFILAMENT BIOSYN SUTURE United States Surgical, A Division of Tyco Healthc GAM Class II 2000-03-30
K993970 MICRINS MICROSURGICAL SUTURE Micrins Surgical, Inc. GAR Class II 2000-03-30
K993201 HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES Pamitex Industries Sdn Bhd KGO Class I 2000-03-29
K000060 GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007 Senorx, Inc. GDW Class II 2000-03-27
K000728 MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE Medtronic Xomed FST Class II 2000-03-21
K994319 MODULAP Atc Technologies, Inc. GEI Class II 2000-03-20
K992180 VISAGE COSMETIC SURGERY, MODEL V5000 Arthrocare Corp. GEI Class II 2000-03-20
K000417 CONVERTORS EQUIPMENT DRAPES Allegiance Healthcare Corp. KKX Class II 2000-03-17
K000501 ELECTROSURGICAL GENERATOR, MODEL S1 Somnus Medical Technologies, Inc. GEI Class II 2000-03-17
K990504 MEMOTHERM COLORECTAL STENT C.R. Bard, Inc. MQR Class II 2000-03-16
K994365 DYONICS ELECTROBLADE Smith & Nephew, Inc. GEI Class II 2000-03-13
K000498 COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER Lumenis, Inc. GEX Class II 2000-03-13
K000490 CYNOSURE PHOTOGENICA VLS-STAR Cynosure, Inc. GEX Class II 2000-03-13
K000511 MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINE WANDS Arthrocare Corp. GEI Class II 2000-03-13
K990718 ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) Laserscope GEX Class II 2000-03-08
K000608 SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM Std Mfg., Inc. GDW Class II 2000-03-07
K000250 CAUTERY FORCEPS WITH FOOTSWITCH Starion Instruments GEI Class II 2000-03-07
K000296 STARION CAUTERY HOOK Starion Instruments GEI Class II 2000-03-07
K994428 E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE Valleylab, Inc. GEI Class II 2000-03-07
K991798 ACME MEDICAL AESTHETIC ND:YAG LASER Altus Medical GEX Class II 2000-03-06
K993170 MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS Medline Industries, Inc. FYA Class II 2000-03-02
K994328 SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX Genzyme Corp. FTL Class II 2000-03-02
K994151 PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES Ximed/Prosure/Injectx GAA Class I 2000-03-01
K994014 ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT Esc Medical Systems , Ltd. GEX Class II 2000-02-24
K000228 ENTEC CONTROLLER, ENTEC PATIENT CABLE, FOOTSWITCH, POWERCORD, PLASMA WAND Arthrocare Corp. GEI Class II 2000-02-22
K992537 PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED Bio-Vascular, Inc. FTM Class II 2000-02-22
K994244 CONVERTORS SURGICAL GOWNS, STERILE Allegiance Healthcare Corp. FYA Class II 2000-02-18
K992445 MED-GUARD SURGEON'S GOWN Kappler USA FYA Class II 2000-02-18
K993965 CRYO-HIT Galil Medical , Ltd. GEH Class II 2000-02-18
K992556 PERMACOL Tissue Science Laboratories, Plc FTL Class II 2000-02-17
K000295 ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Ansell Perry KGO Class I 2000-02-16
K000185 GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM) W. L. Gore & Associates, Inc. FTL Class II 2000-02-14
K000170 SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000 Conway Stuart Medical, Inc. GEI Class II 2000-02-14
K993885 ULTRABLATOR ELECTRODE Linvatec Corp. JOS Class II 2000-02-10
K994001 POLYGLYCOLIC ACID Trading Consultants and Distributors Intl., Inc. GAM Class II 2000-02-09
K994177 SUTRASILK SILK SUTURE Visionary Medical Supplies, Inc. GAP Class II 2000-02-08
K994262 FRONTAL SINUS TREPHINATION CANNULA Xomed, Inc. KAM Class I 2000-02-08
K994336 BITX PROBES Everest Medical Corp. GEI Class II 2000-02-08
K994176 SUTRALON NYLON SUTURES Visionary Medical Supplies, Inc. GAR Class II 2000-02-08
K994211 ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285 Dentsply Intl. KKX Class II 2000-02-04
K993834 SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C Cardiofocus, Inc. GEX Class II 2000-02-04
K992805 ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES) Oratec Interventions, Inc. GEI Class II 2000-02-04
K000079 NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M Nikomed U.S.A., Inc. HAM Class II 2000-02-04
K000036 ENTEC REFLEX WAND 55, MODEL E4055-00 Arthrocare Corp. GEI Class II 2000-02-04
K994160 COALESCENT SURGICAL SUTURED-CLIP Coalescent Surgical FZP Class II 2000-02-04
K994002 PLAIN/CHROMIC CATGUT Trading Consultants and Distributors Intl., Inc. GAL Class II 2000-02-04
K993998 NYLON Trading Consultants and Distributors Intl., Inc. GAR Class II 2000-02-04
K993785 ULTRACLIP TISSUE MARKER Inrad GDW Class II 2000-02-04
K994000 POLYESTER Trading Consultants and Distributors Intl., Inc. GAT Class II 2000-02-04
K000074 ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA SCALPEL GS, TURBOVAC GS Arthrocare Corp. GEI Class II 2000-02-04
K993999 SILK Trading Consultants and Distributors Intl., Inc. GAP Class II 2000-02-04
K993997 POLYPROPYLENE Trading Consultants and Distributors Intl., Inc. GAW Class II 2000-02-04
K993911 CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50 Ceram Optec, Inc. GEX Class II 2000-02-01
K000044 ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINEWANDS Arthrocare Corp. GEI Class II 2000-02-01
K993828 CERALAS D10 810NM DIODE LASER Ceram Optec, Inc. GEX Class II 2000-02-01
K990530 KERLIX MD ANTIMICROBIAL GAUZE DRESSING The Kendall Company, L.P. NAD Class I 2000-01-31
K993857 THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR Ansell Perry KGO Class I 2000-01-31
K992604 HENRY SCHEIN SURGICAL MASK Mitsui Textile Corp. FXX Class II 2000-01-28
K991935 EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM Esc Medical Systems , Ltd. GEX Class II 2000-01-27
K992045 ELECTROSURGICAL ELECTRODE FAMILY Genesis Medical, Inc. GEI Class II 2000-01-27
K992991 ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT Atrium Medical Corp. FTL Class II 2000-01-27
K992914 EXCIMER LASER PHOTOTHERAPY SYSTEM, AL7000 Acculase, Inc. GEX Class II 2000-01-27
K993671 CANDELA SCLERO LONG PULSE DYE LASER Candela Corp. GEX Class II 2000-01-24
K992855 XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT Xomed, Inc. QPB Class II 2000-01-21
K994173 STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTECH RADIOFREQUENCY GENERATOR, MODEL 1025A-230 Stellartech Research Corp. GEI Class II 2000-01-20
K992436 GOWN BACK, MODEL 13-403N; 13-404N; 13-405N Techstyles FYA Class II 2000-01-20
K994273 MODEL 1000 HOLMIUM LASER SYSTEM New Star Lasers, Inc. GEX Class II 2000-01-20
K994081 SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES Safeskin Corp. KGO Class I 2000-01-18
K994427 CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL Cynosure, Inc. GEX Class II 2000-01-18
K992448 V.A.C. PLUS Kinetic Concepts, Inc. OMP Class II 2000-01-18
K994333 ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES Oratec Interventions, Inc. GEI Class II 2000-01-18
K994437 CYNOSURE PHOTOGENICA SPIR Cynosure, Inc. GEX Class II 2000-01-18
K993942 LITESABER 2000 Laser Dental Innovations GEX Class II 2000-01-18
K994313 MODIFICATION TO BONE ANCHOR AND KIT (BAK) Axya Medical, Inc. GAW Class II 2000-01-13
K993795 CONVERTORS SURGICAL DRAPES Allegiance Healthcare Corp. KKX Class II 2000-01-12
K993562 POWDER FREE LATEX STERILE SURGICAL GLOVES Tg Medical Sdn. Bhd. KGO Class I 1999-12-29
K993450 LATEX SURGICAL GLOVES, PRE-POWDERED Fitco Dipped Products Pvt., Ltd. KGO Class I 1999-12-29
K992482 DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM) Radiancy, Ltd. GEX Class II 1999-12-27
K994075 GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435 Geiger Medical Technologies, Inc. GEI Class II 1999-12-27
K993209 SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORY Thermolase Corp. GEX Class II 1999-12-23
K993424 THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP Y-Clip Associates FZP Class II 1999-12-23
K993655 MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS Xomed, Inc. GEI Class II 1999-12-21

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