Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 25
- Latest Decision
- 2001-01-17
Clearances · page 83 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K003895 | X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21 | Ansell Perry | KGO | Class I | 2001-01-17 |
| K003771 | ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Ansell Healthcare Products, Inc. | KGO | Class I | 2001-01-16 |
| K003202 | FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II | Altus Medical | GEX | Class II | 2001-01-10 |
| K003151 | MICROPOBE SERIES OF LASERS AND ACCESSORIES | Endooptiks, Inc. | GEX | Class II | 2001-01-08 |
| K002488 | KELO-COTE TOPICAL GEL | Advanced Bio-Technologies, Inc. | MDA | Class I | 2001-01-05 |
| K003462 | ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045 | Erbe USA, Inc. | GEI | Class II | 2001-01-04 |
| K002269 | ELECTROSURGICAL PROBES AND DEVICES-GELTX | Ximed/Prosure/Injectx | GEI | Class II | 2001-01-04 |
| K001738 | DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT | DePuy Orthopaedics, Inc. | FTM | Class II | 2000-12-27 |
| K003050 | CRYOSURGICAL UNIT AND ACCESSORIES | Cryogen, Inc. | GEI | Class II | 2000-12-26 |
| K003769 | ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87 | Ansell Healthcare Products, Inc. | KGO | Class I | 2000-12-22 |
| K001955 | AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250 | Aaron Medical Industries | GEI | Class II | 2000-12-22 |
| K003277 | SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33 | Powermed, Inc. | GDW | Class II | 2000-12-21 |
| K003337 | HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240 | Weck Closure Systems | FZP | Class II | 2000-12-21 |
| K002308 | OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A | Trimedyne, Inc. | GEX | Class II | 2000-12-20 |
| K003100 | WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM | Boston Scientific Corp | JCT | Class II | 2000-12-20 |
| K003624 | REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWITCH, REFINITY POWER CORD, MODEL V5100-00,V5701-00,V5702 | Arthrocare Corp. | GEI | Class II | 2000-12-20 |
| K003781 | COOLTOUCH VARIA-II ND:YAG LASER SYSTEM | Cooltouch Corp. | GEX | Class II | 2000-12-20 |
| K002999 | GRAMS POLYPROPYLENE NONABSORBABLE SUTURE | Gramsmed, LLC | GAW | Class II | 2000-12-18 |
| K003092 | MODIFICATION TO VNUS CLOSURE SYSTEM | Vnus Medical Technologies, Inc. | GEI | Class II | 2000-12-18 |
| K003000 | GRAMS NYLON NONABSORBABLE SUTURE | Gramsmed, LLC | GAR | Class II | 2000-12-18 |
| K003001 | GRAMS SILK NONABSORBABLE SUTURE | Gramsmed, LLC | GAP | Class II | 2000-12-15 |
| K003015 | SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD | Surgical Specialties Corp | GAN | Class II | 2000-12-15 |
| K003147 | LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION) | Laserscope | GEX | Class II | 2000-12-15 |
| K003249 | PST ELECTROSURGICAL GENERATOR, MODEL 2150, PST BIPOLAR FORCEPS, MODEL EBF 1228 | Pst, Inc. | GEI | Class II | 2000-12-12 |
| K002899 | OPUS 20, MODEL 1ST | Opusdent , Ltd. | GEX | Class II | 2000-12-12 |
| K003005 | TISSUELINK BIPOLAR FORCEPS | Tissuelink Medical, Inc. | GEI | Class II | 2000-12-08 |
| K003183 | THERMAGE THERMACOOL II SYSTEM | Thermage, Inc. | GEI | Class II | 2000-12-08 |
| K003674 | NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, NEEDLE TIP, BALL TIP | Davol Inc., Sub. C. R. Bard, Inc. | GEI | Class II | 2000-12-08 |
| K003169 | VASCULAR CLOSURE DEVICE | Std Mfg., Inc. | GDW | Class II | 2000-12-08 |
| K002841 | COOL-TEC ELECTRODES | Seedling Enterprises., LLC | GEI | Class II | 2000-12-08 |
| K002691 | COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE | Com-Med International, Inc. | KKX | Class II | 2000-12-08 |
| K001895 | AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER | United States Surgical, A Division of Tyco Healthc | GDW | Class II | 2000-12-08 |
| K002987 | REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE | Xomed, Inc. | GEI | Class II | 2000-12-04 |
| K002884 | PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES | Fotona D.D. | GEX | Class II | 2000-12-04 |
| K003587 | CLEARGLIDE PRECISION BIPOLAR DEVICE | ETHICON, Inc. | GEI | Class II | 2000-12-04 |
| K002853 | SCITON IMAGE HAIR REMOVAL LASER | Sciton, Inc | GEX | Class II | 2000-12-04 |
| K001211 | MODIFICATION TO INTRALASE 600C LASER KERATOME | Intra Lase Corp. | GEX | Class II | 2000-12-04 |
| K002593 | POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | Hartalega Sdn Bhd | KGO | Class I | 2000-11-29 |
| K002721 | AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH | American Medical Systems, Inc. | FTL | Class II | 2000-11-29 |
| K002714 | WARTNER WART REMOVAL SYSTEM | Wartner Medical Products | GEH | Class II | 2000-11-28 |
| K003046 | IMAGE VASCULAR LASER | Sciton, Inc | GEX | Class II | 2000-11-24 |
| K003028 | CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC | Osteogenics Biomedical, Inc. | NBY | Class II | 2000-11-24 |
| K002886 | IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) | Implantech Associates, Inc. | LZK | Class II | 2000-11-24 |
| K002672 | VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH | ETHICON, Inc. | FTL | Class II | 2000-11-22 |
| K003063 | GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION | Gimbel Glove Co., LLC | KGO | Class I | 2000-11-22 |
| K002649 | ARAMIS DERMATOLOGICAL LASER | Palomar Medical Technologies, Inc. | GEX | Class II | 2000-11-21 |
| K003471 | MAGNA TEK ESU-400 | Huttinger Medizintechnik GmbH & CO KG | GEI | Class II | 2000-11-20 |
| K002752 | BAYONET FORCEPS BIPOLAR IRRIGATING | Q2 Medical | GEI | Class II | 2000-11-20 |
| K002586 | MEDPOR PTERIONAL SURGICAL IMPLANT | Porex Surgical Products Group | MNF | Class II | 2000-11-17 |
| K002615 | SURGICAL SYSTEM WITH CRYOGUIDE | Endocare, Inc. | GEH | Class II | 2000-11-13 |
| K001440 | NEXTSTITCH CARDIOVASCULAR VALVE SUTURE | Genzyme Surgical Product (Genzyme Biosurgery) | GAT | Class II | 2000-11-13 |
| K002680 | TISSUELINK MONOPOLAR FLOATING BALL' | Tissuelink Medical, Inc. | GEI | Class II | 2000-11-13 |
| K002463 | STELLAR | Skytron, Div. the Kmw Group, Inc. | FSY | Class II | 2000-11-08 |
| K000023 | FRIENDLY LIGHT ER:YAG PULSED LASER | Innotech USA, Inc. | GEX | Class II | 2000-11-06 |
| K003019 | PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE | Wrp Asia Pacific Sdn. Bhd. | KGO | Class I | 2000-11-03 |
| K002421 | CANDELA MID IR DIODE LASER SYSTEM | Candela Corp. | GEX | Class II | 2000-11-03 |
| K002582 | PILLING E-FRAZIER BIPOLAR SUCTION TUBE | Pilling | GEI | Class II | 2000-11-03 |
| K001676 | OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A | Trimedyne, Inc. | GEX | Class II | 2000-11-02 |
| K003065 | SEEDNET, MODEL EP6T5, EP5E5 | Galil Medical , Ltd. | GEH | Class II | 2000-10-31 |
| K003060 | PLASMAKINETIC GENERATOR | Everest Medical Corp. | GEI | Class II | 2000-10-31 |
| K000317 | SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM | Tissue Medical Lasers, Inc. | GEX | Class II | 2000-10-27 |
| K003194 | STACKHOUSE LENS HOOD, MODEL SA-700/FS | Stackhouse, Inc. | FYA | Class II | 2000-10-26 |
| K002702 | NEUROTOLOGY DRAPE, MODEL TBD | Gyrus Ent LLC | KKX | Class II | 2000-10-26 |
| K002261 | MR-III | Smith & Nephew, Inc. | GAS | Class II | 2000-10-23 |
| K001990 | DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES | Depilase Group , Ltd. | GEX | Class II | 2000-10-23 |
| K002479 | BIOMESH P1 AND BIOMESH PLUG AND PATCH | Cousin Biotech S.A.R.L | FTL | Class II | 2000-10-19 |
| K002933 | STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES | Maxxim Medical | KGO | Class I | 2000-10-19 |
| K002257 | TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 | Tecno Instruments (Pvt.) , Ltd. | GEI | Class II | 2000-10-19 |
| K002898 | CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST | Curon Medical, Inc. | GEI | Class II | 2000-10-17 |
| K000929 | PROLITE PULSED LIGHT SYSTEM | Medical Bio Care Sweden AB | GEX | Class II | 2000-10-17 |
| K002233 | BVI SLING | Bio-Vascular, Inc. | PAJ | Class II | 2000-10-13 |
| K002684 | COMPOSIX E/X MESH | C.R. Bard, Inc. | FTL | Class II | 2000-10-11 |
| K002557 | SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN) | Axya Medical, Inc. | GAW | Class II | 2000-10-06 |
| K991296 | TUTOPATCH | Tutogen Medical U.S., Inc. | FTM | Class II | 2000-10-06 |
| K002094 | BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE | C.R. Bard, Inc. | ESW | Class II | 2000-10-06 |
| K002228 | PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X | Paradigm Medical Industries, Inc. | GEX | Class II | 2000-10-06 |
| K001703 | PERCLOSE VASCULAR SUTURE DELIVERY DEVICE | Abbott Vascular, Inc. | GAW | Class II | 2000-10-03 |
| K002296 | CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15 | Ceram Optec, Inc. | GEX | Class II | 2000-10-02 |
| K001986 | SURGITRON IEC II | Ellman Intl., Inc. | GEI | Class II | 2000-09-27 |
| K000727 | BUFFLIGHT CLT SURGICAL LASER SYSTEM | Y-Beam Technologies, Inc. | GEX | Class II | 2000-09-19 |
| K001093 | CANDELA SPTL-1B PULSED DYE LASER | Candela Corp. | GEX | Class II | 2000-09-19 |
| K002072 | PROLITE VL PULSED LIGHT SYSTEM | Medical Bio Care Sweden AB | GEX | Class II | 2000-09-11 |
| K001784 | VIRIDIS LASER | Cosmos Medical Technology | GEX | Class II | 2000-09-11 |
| K002032 | C02 LASER MULTIPULSE | Asclepion-Meditec AG | GEX | Class II | 2000-09-11 |
| K001951 | PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306 | Primeline Medical Products, Inc. | FXX | Class II | 2000-09-08 |
| K002508 | EQUIPMENT DRAPES | Allegiance Healthcare Corp. | KKX | Class II | 2000-09-01 |
| K002109 | OLEEVA FOAM | Bio Med Sciences, Inc. | MDA | Class I | 2000-08-31 |
| K001704 | ATHOS | Cosmos Medical Technology | GEX | Class II | 2000-08-31 |
| K002422 | VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM | Mitek Products | GEI | Class II | 2000-08-31 |
| K002351 | FLUOROTEX II SURGICAL MESH | Bridger Biomed, Inc. | FTL | Class II | 2000-08-26 |
| K000811 | NLITE SYSTEM, SLS MODEL NUMBER A00-1025 | Sls Biophile , Ltd. | GEX | Class II | 2000-08-25 |
| K000158 | VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9 | Fisma, Inc. | GEX | Class II | 2000-08-24 |
| K002021 | HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE | Gyrus Ent LLC | GEI | Class II | 2000-08-24 |
| K002435 | MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK) | Axya Medical, Inc. | GAW | Class II | 2000-08-24 |
| K001589 | CANDELA DYNAMIC COOLING DEVICE | Candela Corp. | GEX | Class II | 2000-08-18 |
| K002347 | COOLTOUCH II | New Star Lasers, Inc. | GEX | Class II | 2000-08-17 |
| K000605 | STACKHOUSE LENS HOOD, MODEL SA-700/F | Stackhouse, Inc. | FYA | Class II | 2000-08-17 |
| K002002 | SUREFIT DISPERSIVE ELECTRODE | Conmedcorp | GEI | Class II | 2000-08-17 |
| K001858 | OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE | China Nantong Guangda Textile Co., Ltd. | KKX | Class II | 2000-08-17 |
| K002419 | SURGICAL DRAPES | Allegiance Healthcare Coporation | KKX | Class II | 2000-08-15 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.