Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 41
- Latest Decision
- 1992-07-30
Clearances · page 116 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K920437 | SYNTHETIC ABSORBABLE SUTURE, UNDYED | ETHICON, Inc. | GAW | Class II | 1992-07-30 |
| K922614 | TURKEL THORACENTESIS SYSTEM | Symbiosis Corp. | GAA | Class I | 1992-07-30 |
| K915845 | HAIR TRONICS MODEL HT8000 | Global Tronics Intl., Inc. | KCX | Class I | 1992-07-29 |
| K921096 | LASER-6 | Laser Endo Technic | GEX | Class II | 1992-07-28 |
| K913244 | KTP/532 & KTP/YAG SURGICAL LASERS | Charles L. Rose and Co., Inc. | GEX | Class II | 1992-07-28 |
| K914918 | LASERSCOPE'S MICROSPOT DERMASTAT | Laserscope | GEX | Class II | 1992-07-24 |
| K913302 | DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED | Carwild Corp. | GDY | Class I | 1992-07-23 |
| K915608 | BICUT | Berchtold Holding GmbH | GEI | Class II | 1992-07-23 |
| K920217 | MAX-E-VAC | Leisegang Medical, Inc. | GEI | Class II | 1992-07-23 |
| K914136 | COHERENT VERSAPULSE(TM) 2.1XE/2.1L HOLMI SURG LASE | Coherent Medical Group | GEX | Class II | 1992-07-21 |
| K922659 | GENERAL SURGERY CLAMP AND NEEDLE HOLDER | Miltex Instrument Co. | GDJ | Class I | 1992-07-21 |
| K920071 | MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 | Medical Devices, Inc. | GEI | Class II | 1992-07-21 |
| K921051 | 3M PRECISE BRAND INTERNAL SURGICAL STAPLES | 3M Health Care, Ltd. | GDW | Class II | 1992-07-16 |
| K921840 | CYNOSURE PHOTOTRIPTER LASER | Cynosure, Inc. | GEX | Class II | 1992-07-16 |
| K921934 | INTRADUCER | Taut, Inc. | GBX | Class I | 1992-07-15 |
| K922634 | SLT LASER DELIVERY SYSTEM | Surgical Laser Technologies, Inc. | GEX | Class II | 1992-07-15 |
| K921842 | CYNOSURE PHOTGENICA V CUTANEOUS VAS. LESION LASER | Cynosure, Inc. | GEX | Class II | 1992-07-08 |
| K920967 | ZEISS MULTI YAG LASER | Carl Zeiss, Inc. | GEX | Class II | 1992-07-08 |
| K921866 | LUMINOUS 250 FIBEROPTIC ILLUMINATOR | Progressive Dynamics, Inc. | HBI | Class II | 1992-07-08 |
| K922375 | EXCEL DUOPULSE MODEL 3000 COMBINATION HO/ER:YAG | Excel Tech. , Ltd. | GEX | Class II | 1992-07-08 |
| K921298 | MODEL MM-2405 AND MM-2410 COPPER VAPOR LASER | Cj Laser Corp. | GEX | Class II | 1992-07-02 |
| K920045 | DURATECH HOSPITAL TOWEL | Techstyles | KKX | Class II | 1992-07-02 |
| K921320 | ELIOS DIODE OPHTHALMIC LASER | Marco Ophthalmic, Inc. | GEX | Class II | 1992-07-02 |
| K920890 | OPERATING TABLE SYSTEM-BETAMAQUET 1140 | Stierlen-Maquet AG | FQO | Class I | 1992-07-02 |
| K920153 | THERMUFF BAG | Techstyles | KDC | Class I | 1992-07-01 |
| K920288 | POWERED VACUUM ASPIRATOR 1110-G-062 | Stirn Industries | JCX | Class II | 1992-06-29 |
| K920287 | POWERED VACUUM ASPIRATOR 1110-G-030 | Stirn Industries | JCX | Class II | 1992-06-29 |
| K921380 | LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER | Laserscope | GEX | Class II | 1992-06-25 |
| K915679 | EXCEL DUOPAULSE MODEL 2000 | Excel Tech. , Ltd. | GEX | Class II | 1992-06-24 |
| K920471 | LEVY ARTICULATING RETRACTOR | Lifeguard Medical Products, Inc. | GAD | Class I | 1992-06-23 |
| K915740 | DISPOSABLE O.R. TOWEL, STERILE | American Threshold Industries, Inc. | KKX | Class II | 1992-06-22 |
| K921418 | ULTRA-CORE BIOPSY NEEDLES | Medical Device Technologies, Inc. | DWO | Class I | 1992-06-19 |
| K921807 | ULTRALINE STERILE DISPOSABLE FIBER | Heraeus Lasersonics, Inc. | GEX | Class II | 1992-06-18 |
| K921671 | SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE | Surgical Products Corp. | GEX | Class II | 1992-06-18 |
| K915086 | HPI BROWN NITRILE SENSI-GRIP SURGICAL GLOVES | Hpi, Inc. | KGO | Class I | 1992-06-17 |
| K912067 | POLARIS, GYNECOLOGY INDICATIONS | Pfizer Laser Systems | GEX | Class II | 1992-06-16 |
| K915578 | ND;YAG SURGICAL LASER SYSTEMS | Heraeus Lasersonics, Inc. | GEX | Class II | 1992-06-15 |
| K915651 | OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM | Summit Technology, Inc. | GEX | Class II | 1992-06-15 |
| K915631 | LPI ML 100/532 AND ML 532 SURGICAL LASER | Laser Photonics, Inc. | GEX | Class II | 1992-06-15 |
| K914588 | GRIESHABER SNARE INSTRUMENT AND SNARE CARTRIDGE | Grieshaber & Co. | GAW | Class II | 1992-06-11 |
| K914753 | AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP | United States Surgical, A Division of Tyco Healthc | GET | Class I | 1992-06-11 |
| K922348 | VALTRAC(R) INTRODUCER FORCEP | American Cyanamid Co. | HJE | Class II | 1992-06-09 |
| K921131 | CKS OSCILLATING SAW BLADE | Techmedica, Inc. | HWE | Class I | 1992-06-08 |
| K921146 | SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40 | Sharplan Lasers, Inc. | GEX | Class II | 1992-06-08 |
| K920659 | DAVOL ENDO-FLO LASER PROBE AND ACCESSORIES | Davol, Inc. | GEX | Class II | 1992-06-05 |
| K920062 | CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS. | Candela Laser Corp. | GEX | Class II | 1992-06-05 |
| K915204 | MULTI USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT | Conmedcorp | GEI | Class II | 1992-06-04 |
| K922371 | SPINAL POSITIONING FRAME | Rhino Mfg. | FQO | Class I | 1992-06-04 |
| K920597 | HANDI-LASE CO2 SURGICAL LASER INSTRUMENT | Sorenson Laboratories, Inc. | GEX | Class II | 1992-06-04 |
| K921038 | ECLIPSE 2100 | Cardiogenes | GEX | Class II | 1992-06-04 |
| K915826 | BIO-POLAR FORCEPS | Applied Medical | GEI | Class II | 1992-06-02 |
| K920995 | BARRIER DRAPE SHEET WITH SYMETRY FABRIC | Johnson & Johnson Medical, Inc. | KKX | Class II | 1992-05-31 |
| K920996 | BARRIER SURGICAL GOWN WITH SYMETRY FABRIC | Johnson & Johnson Medical, Inc. | FYA | Class II | 1992-05-31 |
| K910449 | PRESTITCH | Crantec Co. | KCY | Class I | 1992-05-29 |
| K915821 | MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES | Kerma Medical Products, Inc. | NAB | Class I | 1992-05-29 |
| K921227 | TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE | Courtaulds Fibers, Inc. | NAB | Class I | 1992-05-29 |
| K921349 | STERILE,DISPOSABLE EYE DRESSING | Deroyal Industries, Inc. | HMP | Class I | 1992-05-29 |
| K920847 | ETHICON LIGACLIP ENDO LD APPLIER/DIVIDER | ETHICON, Inc. | FZP | Class II | 1992-05-29 |
| K920282 | PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE | Trinity Laboratories, Inc. | NAB | Class I | 1992-05-29 |
| K915526 | COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH | United States Surgical, A Division of Tyco Healthc | FTL | Class II | 1992-05-29 |
| K915357 | PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH | Medtronic Vascular | NAE | Class I | 1992-05-28 |
| K915359 | PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH | Medtronic Vascular | NAE | Class I | 1992-05-28 |
| K920283 | DISPOSABLE SKIN STAPLE REMOVER | Trinity Laboratories, Inc. | MCZ | Class I | 1992-05-22 |
| K920837 | STERILE CONVERTOR SAFECARE GOWN AND DRAPE | Baxter Healthcare Corp | FYA | Class II | 1992-05-22 |
| K920821 | UNIMAX MODEL 2000 COLOR-CORRECTED MICROSPOT CO2 | Reliant Laser Corp. | GEX | Class II | 1992-05-21 |
| K920004 | PBI MULTILASE D COPPER VAPOR LASER | Wm.I.Kern & Co., Inc. | GEX | Class II | 1992-05-14 |
| K915066 | DISPOSABLE SKIN MARKER | American Medical Mfg., Inc. | FZZ | Class I | 1992-05-14 |
| K914941 | SIMON BREAST LESION LOCALIZATION NEEDLE | Manan Medical Products, Inc. | GDF | Class I | 1992-05-14 |
| K921596 | SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECE | Sharplan Lasers, Inc. | GEX | Class II | 1992-05-13 |
| K921646 | NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON | Nextec Corp. | FST | Class II | 1992-05-13 |
| K920517 | MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP | Trinity Laboratories, Inc. | KKX | Class II | 1992-05-11 |
| K920280 | SUTURE REMOVAL KIT, STERILE, DISPOSABLE | Trinity Laboratories, Inc. | MCZ | Class I | 1992-05-11 |
| K921535 | SUOENA AFFINITY (TM) MODEL #802 | Coloplast Corp. | KCZ | Class I | 1992-05-11 |
| K921582 | FLOWERS MEDIAL MALAR IMPLANT | Implantech Associates, Inc. | LZK | Class II | 1992-05-06 |
| K920643 | LAPAROSCOPIC SUCTION/IRRIGATION PROBE | O.R. Concepts, Inc. | GBZ | Class I | 1992-05-06 |
| K920263 | MANUAL SURGICAL INSTRUMENTS | Phoenix Instruments Div. | KDC | Class I | 1992-05-06 |
| K921580 | BRINK PRE-MAXILLARY IMPLANT | Implantech Associates, Inc. | FZE | Class II | 1992-05-06 |
| K921581 | CHIN WAFER | Implantech Associates, Inc. | FWP | Class II | 1992-05-06 |
| K914991 | VERSAPULSE(TM) TWOPOINTONE/XE HOLMIUM SURG LASERS | Coherent Medical Group | GEX | Class II | 1992-05-06 |
| K914190 | AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR | United States Surgical, A Division of Tyco Healthc | GAD | Class I | 1992-05-06 |
| K921091 | CHOLANGIOLAPCATH(TM) | Bd Becton Dickinson Vacutainer Systems Preanalytic | GBZ | Class I | 1992-05-06 |
| K914615 | BTP(TM) CENTRALINE(TM) SUIT | Btp Industries, Inc. | FXO | Class I | 1992-05-05 |
| K915119 | SCALPEL BLADE REMOVER (BLADEGARD) | Intergrated Visual, Inc. | GES | Class I | 1992-05-05 |
| K921626 | TELETOM(R) | Berchtold Holding GmbH | FQO | Class I | 1992-05-05 |
| K921464 | CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT | Trinity Laboratories, Inc. | GBQ | Class I | 1992-05-05 |
| K915175 | REDDICK RETRACTOR | Ideal Medical, Inc. | GAD | Class I | 1992-04-29 |
| K915502 | MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPES | Medline | FYA | Class II | 1992-04-29 |
| K921095 | PACER DISPOSABLE YANKAUER SUCTION INSTRUMENT | Pacer Tool & Plastics, Inc. | GBX | Class I | 1992-04-29 |
| K921210 | SURGICAL INSTRUMENT STAND | Murphy Medical Center | MDM | Class I | 1992-04-29 |
| K920934 | HALOCATH LASER CATHETERS | Trimedyne, Inc. | GEX | Class II | 1992-04-29 |
| K920589 | ANGLED DELIVERY DEVICE | Laserscope | GEX | Class II | 1992-04-29 |
| K920682 | PHOENIX STERI-TECH STERILE DENTAL PACK GEN-10001 | Phoenix Steri-Tech, Inc. | FXX | Class II | 1992-04-28 |
| K920341 | LACERATION TRAYS | Medikmark, Inc. | KKX | Class II | 1992-04-23 |
| K912070 | SIEMENS RADIOTOM 904 & 904E ELECTROSURGERY UNIT | Siemens Medical Electronics | GEI | Class II | 1992-04-23 |
| K920340 | SUTURE REMOVAL KIT | Medikmark, Inc. | KKX | Class II | 1992-04-23 |
| K914445 | PERRY(R) NATURAL POWDER-FREE GLOVES, STYLE 45 | Smith & Nephew Perry | KGO | Class I | 1992-04-22 |
| K920269 | EZ GAUZE SPONGE | Cal West Trading Co. | NAB | Class I | 1992-04-22 |
| K920816 | PERCUGUIDE LESION MARKING | E-Z-Em, Inc. | GDF | Class I | 1992-04-21 |
| K915182 | DEROYAL HYDROGEL DRESSING | Deroyal Industries, Inc. | NAE | Class I | 1992-04-21 |
| K914759 | BLOOM TRANSPARENT STENCIL | Freckles Publications, Inc. | FZZ | Class I | 1992-04-21 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.