Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 28
- Latest Decision
- 2000-08-14
Clearances · page 84 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K000421 | BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE | Ssl Americas, Inc. (Regent Medical) | KGO | Class I | 2000-08-14 |
| K002190 | POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) | Cp Medical | GAM | Class II | 2000-08-10 |
| K001162 | GOLDFINGER DEVICE | Mali-Tech , Ltd. | FMK | Class II | 2000-08-09 |
| K001994 | EEI SLUSH PAN DRAPE | Eagle Endoscopic, Inc. | KKX | Class II | 2000-08-04 |
| K001803 | ACCELERATOR RECIPROCATING CANNULA | Byron Medical | QPB | Class II | 2000-08-04 |
| K001975 | CERALAS D10 810NM LASER, MODEL CERALAS D10-60 | Ceram Optec, Inc. | GEX | Class II | 2000-08-04 |
| K001527 | FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES | Fotona D.D. | GEX | Class II | 2000-07-27 |
| K002192 | DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38 | Ansell Perry | KGO | Class I | 2000-07-27 |
| K990119 | EPI-STAR SURGICAL LASER SYSTER | Nidek, Inc. | GEX | Class II | 2000-07-27 |
| K001959 | POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) | Hartalega Sdn Bhd | KGO | Class I | 2000-07-26 |
| K001608 | BLAINE SCARCARE PATCH | Blaine Labs, Inc. | MDA | Class I | 2000-07-25 |
| K002071 | SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES | Tissue Technologies, Inc. | FTL | Class II | 2000-07-24 |
| K001407 | SURGITRON IEC II | Ellman Intl., Inc. | GEI | Class II | 2000-07-24 |
| K002093 | ATRIUM LITE MESH | Atrium Medical Corp. | FTL | Class II | 2000-07-24 |
| K001723 | COOL-TEC ELECTRODES | Seedling Enterprises., LLC | GEI | Class II | 2000-07-19 |
| K000944 | THERMAGE THERMACOOL SYSTEM | Thermage, Inc. | GEI | Class II | 2000-07-19 |
| K001511 | O-LAS OPHTHALMIC PHOTODISRUPTOR | A.R.C. Laser AG | GEX | Class II | 2000-07-19 |
| K001746 | LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS) | Coherent Star | GEX | Class II | 2000-07-19 |
| K001716 | REDON SET | Pfm Produkte Fur Die Medizin AG | JCX | Class II | 2000-07-19 |
| K001936 | ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD | Arthrocare Corp. | GEI | Class II | 2000-07-19 |
| K001450 | AUTO SUTURE MICRO SURGICLIP CLIP APPLIER | United States Surgical, A Division of Tyco Healthc | FZP | Class II | 2000-07-18 |
| K993328 | SURGILIGHT, INC EXCIMER LASER | Surgilight, Inc. | GEX | Class II | 2000-07-18 |
| K001904 | ARTHROCARE FLOW CONTROL UNIT | Arthrocare Corp. | GEI | Class II | 2000-07-17 |
| K001924 | COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0 | Allegiance Healthcare Corp. | KGO | Class I | 2000-07-14 |
| K000902 | KLINIDRAPE REINFORCED SURGICAL GOWNS | Molnlycke Health Care, Inc. | FYA | Class II | 2000-07-11 |
| K001625 | PRONOVA NONABSORBABLE SUTURE, USP | ETHICON, Inc. | GAW | Class II | 2000-07-10 |
| K001789 | SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL | W. L. Gore & Associates, Inc. | OXD | Class II | 2000-07-06 |
| K000901 | KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION | Molnlycke Health Care, Inc. | FYA | Class II | 2000-07-05 |
| K001322 | PERFORMER 30 HPS | Cornelia Damsky, Inc. | GEX | Class II | 2000-06-30 |
| K001031 | URANUS, COMFORTOUCH LASER SYSTEM | Laser Max Medical Technologies Corp. | GEX | Class II | 2000-06-29 |
| K992757 | CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER | Cynosure, Inc. | GEX | Class II | 2000-06-29 |
| K993154 | LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM | A.R.C. Laser Corp. | GEX | Class II | 2000-06-29 |
| K001150 | ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE | Novasys Medical, Inc. | GEI | Class II | 2000-06-29 |
| K001151 | ELECTROSURGICAL ELECTRODE FAMILY | Novasys Medical, Inc. | GEI | Class II | 2000-06-27 |
| K001382 | AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR | Aaron Medical Industries | GEI | Class II | 2000-06-27 |
| K001172 | POLYESTER NONABSORBABLE SURGICAL SUTURES URP | Cp Medical | GAT | Class II | 2000-06-23 |
| K001667 | RESOLVE SURGICAL O.R. TOWELS | Allegiance Healthcare Corp. | KKX | Class II | 2000-06-23 |
| K001223 | ACULUX, MODEL AX3001, AX3002 | Aculux | FQP | Class II | 2000-06-23 |
| K001299 | PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP | Cp Medical | GAL | Class II | 2000-06-23 |
| K001184 | SILK, NONABSORBABLE, SURGICAL SUTURES, USP | Cp Medical | GAP | Class II | 2000-06-23 |
| K000990 | OPUS 10 DENTAL DIODE LASER | Opusdent , Ltd. | GEX | Class II | 2000-06-23 |
| K001185 | POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP | Cp Medical | GAW | Class II | 2000-06-23 |
| K001274 | LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Pt. Maja Agung Latexindo | KGO | Class I | 2000-06-23 |
| K000906 | KLINIDRAPE SURGICAL DRAPES | Molnlycke Health Care, Inc. | KKX | Class II | 2000-06-23 |
| K001173 | NYLON, NONABSORBABLE SURGICAL SUTURES USP | Cp Medical | GAR | Class II | 2000-06-23 |
| K000278 | VIVANT MEDICAL BIOPSY MARKER SYSTEM | Vivant Medical, Inc. | FZP | Class II | 2000-06-23 |
| K001082 | STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100 | Stackhouse, Inc. | FYD | Class II | 2000-06-15 |
| K001262 | THERMAL CAUTERY FORCEPS | Starion Instruments | GEI | Class II | 2000-06-14 |
| K001273 | STARION INSTRUMENTS POWER POINT CAUTERY CLAMP | Starion Instruments | GEI | Class II | 2000-06-14 |
| K001593 | MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL | Chester Labs, Inc. | GEI | Class II | 2000-06-14 |
| K001434 | 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE | Genzyme Surgical Product (Genzyme Biosurgery) | GAT | Class II | 2000-06-12 |
| K001343 | EUDERMIC PF POWDER-FREE SURGICAL GLOVES | Maxxim Medical, Inc. | KGO | Class I | 2000-06-12 |
| K000072 | DORNIER MEDILAS D SKINPULSE | Dornier Surgical Products, Inc. | GEX | Class II | 2000-06-12 |
| K994199 | VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR | Custom Medical Products, Inc. | KKX | Class II | 2000-06-09 |
| K000904 | PENADAPT 10 | Buffalo Filter Co., Inc. | FYD | Class II | 2000-06-08 |
| K001161 | ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL), | Conmedcorp | GEI | Class II | 2000-06-07 |
| K001159 | HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL | Conmedcorp | GEI | Class II | 2000-06-07 |
| K000001 | WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM | Boston Scientific Scimed, Inc. | JCT | Class II | 2000-06-05 |
| K994116 | LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM) | Aesculap-Meditec North America | GEX | Class II | 2000-06-01 |
| K001302 | ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, PLASMA SCALPEL GS, C | Arthrocare Corp. | GEI | Class II | 2000-05-30 |
| K001330 | SOVEREIGN BIPOLAR INSTRUMENTS | Aesculap, Inc. | GEI | Class II | 2000-05-30 |
| K993991 | HM-930 ELECTROSURGICAL UNIT | Hill-Med, Inc. | GEI | Class II | 2000-05-30 |
| K000720 | SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE | Somnus Medical Technologies, Inc. | GEI | Class II | 2000-05-30 |
| K994260 | CANDELA GENTLELASE GL DERMATOLOGICAL LASER | Candela Corp. | GEX | Class II | 2000-05-26 |
| K001253 | SURGITRON IEC II | Ellman Intl., Inc. | GEI | Class II | 2000-05-26 |
| K000639 | VISIONARY 2000 | Burton Medical Products Corp. | FSY | Class II | 2000-05-25 |
| K001243 | DORNIER MEDILAS H | Dornier Surgical Products, Inc. | GEX | Class II | 2000-05-24 |
| K001029 | GEIGER NEEDLE ADAPTER, MODEL 406 | Geiger Medical Technologies, Inc. | GEI | Class II | 2000-05-23 |
| K001049 | GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS) | Guthrie Medicare Products (Melaka) Sdn Bhd | KGO | Class I | 2000-05-23 |
| K001122 | PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH | ETHICON, Inc. | FTL | Class II | 2000-05-23 |
| K000178 | NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN | Terang Nusa Sdn Bhd | KGO | Class I | 2000-05-23 |
| K000849 | SOFTFORM FACIAL IMPLANT | Tissue Technologies, Inc. | FTL | Class II | 2000-05-19 |
| K000704 | DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) | Dmc Medical, Ltd. | GBX | Class I | 2000-05-19 |
| K001257 | INTRACOIL STENT | Intratherapeutics, Inc. | JCT | Class II | 2000-05-18 |
| K994225 | PALOMAR SLP 2000 | Palomar Medical Technologies, Inc. | GEX | Class II | 2000-05-18 |
| K000932 | ARACHNOPHLEBECTOMY NEEDLE | Advanced Medical Products, Inc. | GAH | Class I | 2000-05-17 |
| K001339 | MRI FASTSYSTEM RETRACTOR SYSTEM | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | GAD | Class I | 2000-05-17 |
| K000693 | UMECO OPTIMA MULTILINE LASER SYSTEM | Medical Laser Solutions, LLC | GEX | Class II | 2000-05-16 |
| K001438 | SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR | Somnus Medical Technologies, Inc. | GEI | Class II | 2000-05-16 |
| K001239 | ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Ansell Perry | KGO | Class I | 2000-05-15 |
| K000179 | NUZONE NITRILE SURGICAL GLOVES POWDER FREE | Terang Nusa Sdn Bhd | KGO | Class I | 2000-05-15 |
| K000503 | MEDART 520 COOLING SYSTEM | Medart Corp. | GEX | Class II | 2000-05-15 |
| K000281 | WALLSTENT ENTERNAL PROSTHESIS | Boston Scientific Corp | MQR | Class II | 2000-05-12 |
| K993815 | UNI-LASER 430 | Medart Corp. | GEX | Class II | 2000-05-11 |
| K001263 | SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040 | E S C Sharplan | GEX | Class II | 2000-05-05 |
| K000805 | KAVO K.E.Y. LASER 1242 | Kavo America | GEX | Class II | 2000-05-04 |
| K993841 | CEMSTOP CEMENT RESTRICTOR | Encore Orthopedics, Inc. | LZN | Class II | 2000-05-04 |
| K000587 | SHUTTLE STOP | Isotis NV | LZN | Class II | 2000-05-04 |
| K000333 | STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD | Triad Surgical Technologies, Inc. | JOS | Class II | 2000-05-03 |
| K000896 | POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS | Fitco Dipped Products Pvt., Ltd. | KGO | Class I | 2000-05-03 |
| K000348 | COLORADO MICRODISSECTION NEEDLE | Stryker Leibinger | GEI | Class II | 2000-05-03 |
| K000778 | ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01 | Arthrocare Corp. | GEI | Class II | 2000-05-03 |
| K000480 | ACTIVE ELECTRODE MONITORING SYSTEM | Electroscope, Inc. | GEI | Class II | 2000-05-02 |
| K000982 | A100 AESTHETIC DIODE LASER | Diomed, Inc. | GEX | Class II | 2000-05-01 |
| K000541 | SILK NONABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | GAP | Class II | 2000-04-28 |
| K001047 | GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED) | Guthrie Medicare Products (Melaka) Sdn Bhd | KGO | Class I | 2000-04-28 |
| K993756 | HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES | Pamitex Industries Sdn Bhd | KGO | Class I | 2000-04-28 |
| K000542 | PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | GAL | Class II | 2000-04-28 |
| K000537 | POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | GAW | Class II | 2000-04-27 |
| K000539 | NYLON NONABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | GAR | Class II | 2000-04-27 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.