Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 43
- Latest Decision
- 1989-02-27
Clearances · page 130 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K884565 | ACUFEX FIXATION BUTTON | Acufex Microsurgical, Inc. | KGS | Class I | 1989-02-27 |
| K890474 | SURGICAL GOWNS | Victoria Slipper Retail & Mfg., Co. | FYA | Class II | 1989-02-23 |
| K890447 | HEMORRHAGE OCCLUDOR | Surgeon Surgical Instrumentation, Inc. | GDW | Class II | 1989-02-23 |
| K883982 | DRENOVAC | Iberhospitex, S.A. | GCY | Class I | 1989-02-23 |
| K890398 | RYAN-STYLE DIRECTED INFUSION MANIPULATOR | Advanced Surgical Products, Inc. | HBI | Class II | 1989-02-17 |
| K883887 | AXIOM ATRAUM WOUND DRAINS | Axiom, Inc. | GBS | Class I | 1989-02-17 |
| K890040 | MODIFIED LABELING & PACKAGING OF SHARPLAN 2100 | Sharplan Lasers, Inc. | GEX | Class II | 1989-02-14 |
| K885090 | HOMER MAMMALOK LOCALIZATION SHIELD | North American Instrument Corp. | LRO | Class II | 1989-02-14 |
| K890128 | FACELOCK FILTER MASK | Alpha Protech, Inc. | FXX | Class II | 1989-02-14 |
| K890309 | MALIS SURGICAL STOOL | Valley Forge Scientific Corp. | FZM | Class I | 1989-02-14 |
| K884503 | ULTRASONIC TRANSMISSION GEL | Herbert Stanley Co. | JOT | Class II | 1989-02-13 |
| K890501 | SECOND ASSISTANT | 3M Company | FWZ | Class I | 1989-02-10 |
| K883849 | REPLICARE (ADDITIONAL CLAIMS) | United Medical | NAD | Class I | 1989-02-08 |
| K890279 | MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER | Trimedyne, Inc. | GEX | Class II | 1989-02-07 |
| K885136 | GRAFT GUARD | Sorex Medical | LZM | Class I | 1989-02-06 |
| K890059 | SHARPLAN COMBINED CO2/ND:YAG LASER MICRO. #749 | Sharplan Lasers, Inc. | GEX | Class II | 1989-02-06 |
| K884425 | GLOVE, SURGICAL | Med-Pak Corp. | KGO | Class I | 1989-02-06 |
| K890374 | ABDOMINAL SPATULA | Kinetic Medical Products | GAF | Class I | 1989-02-03 |
| K885222 | PRECISE ILA AND ILAN SURGICAL STAPLES | 3M Company | GDW | Class II | 1989-02-03 |
| K883556 | LATEX SURGICAL GLOVE (NON STERILE) | Makintech Corp. | KGO | Class I | 1989-02-03 |
| K890170 | SCISSORS | Dhason Brothers, Inc. | LRW | Class I | 1989-02-03 |
| K890326 | HIP FRACTURE STEM SYSTEM - FENESTRATION PLUG | Howmedica Corp. | LZN | Class II | 1989-02-03 |
| K890016 | FACE MASK | Anjudd Intl. | FXX | Class II | 1989-02-03 |
| K882200 | STERILE & NON-STERILE SURGEONS GLOVES | Taroko Ent., Ltd. | KGO | Class I | 1989-02-03 |
| K890366 | ADENOID CURETTE | Kinetic Medical Products | FZS | Class I | 1989-02-03 |
| K890371 | INTESTINAL CRUSHING CLAMP | Kinetic Medical Products | HXD | Class I | 1989-02-03 |
| K890372 | INTESTINAL CLAMP | Kinetic Medical Products | HXD | Class I | 1989-02-03 |
| K890159 | TOWEL CLIPS | Dhason Brothers, Inc. | GDO | Class I | 1989-02-03 |
| K885291 | MODEL 20-CH CARBON DIOXIDE LASER W/ACCESSORIES | Pfizer Laser Systems | GEX | Class II | 1989-02-03 |
| K890368 | KIDNEY CLAMP | Kinetic Medical Products | HXD | Class I | 1989-02-03 |
| K890369 | GALL STONE FORCEPS | Kinetic Medical Products | HTD | Class I | 1989-02-03 |
| K890365 | SEPTUM ELEVATOR | Kinetic Medical Products | GEG | Class I | 1989-02-03 |
| K890373 | HEMORRHOIDAL FORCEPS | Kinetic Medical Products | HTD | Class I | 1989-02-03 |
| K890381 | PARAMETRIUM CLAMP | Kinetic Medical Products | HXD | Class I | 1989-02-03 |
| K890235 | DRESSING SCISSORS | Kinetic Medical Products | LRW | Class I | 1989-02-03 |
| K885273 | MICRO SURGICAL INSTRUMENT SYSTEM | Tava Surgical Instruments | HSZ | Class I | 1989-01-30 |
| K890226 | SURGICAL FORCEPS | Kinetic Medical Products | HTD | Class I | 1989-01-27 |
| K890253 | SURGICAL ELEVATOR | Kinetic Medical Products | GEG | Class I | 1989-01-27 |
| K890260 | BONE SHEARS | Kinetic Medical Products | HTD | Class I | 1989-01-27 |
| K890211 | MICROSURGICAL NEEDLE HOLDERS | Kinetic Medical Products | GDF | Class I | 1989-01-27 |
| K890259 | RIB SHEARS | Kinetic Medical Products | HTD | Class I | 1989-01-27 |
| K890248 | SURGICAL RETRACTORS | Kinetic Medical Products | GAD | Class I | 1989-01-27 |
| K890257 | BONE CUTTING FORCEPS, DOUBLE-ACTION | Kinetic Medical Products | HTD | Class I | 1989-01-27 |
| K890230 | LIGATURE NEEDLES | Kinetic Medical Products | GEG | Class I | 1989-01-27 |
| K890258 | BONE CUTTING FORCEPS, SINGLE-ACTION | Kinetic Medical Products | HTD | Class I | 1989-01-27 |
| K890252 | BONE CURETTE | Kinetic Medical Products | HTF | Class I | 1989-01-27 |
| K890233 | SUTURE CLIP APPLIER/REMOVER | Kinetic Medical Products | GDO | Class I | 1989-01-27 |
| K890250 | SURGICAL WIRE CUTTERS | Kinetic Medical Products | GAD | Class I | 1989-01-27 |
| K890244 | TUBING CLAMP FORCEPS | Kinetic Medical Products | HTD | Class I | 1989-01-27 |
| K890214 | MICROSURGERY RAZOR BLADE HOLDER | Kinetic Medical Products | EMF | Class I | 1989-01-27 |
| K890247 | SURGICAL RETRACTORS | Kinetic Medical Products | GAD | Class I | 1989-01-27 |
| K890263 | CILIA FORCEPS | Kinetic Medical Products | HTD | Class I | 1989-01-27 |
| K890215 | MICROSURGICAL SCARIFIER | Kinetic Medical Products | EMF | Class I | 1989-01-27 |
| K890262 | LUNG FORCEPS | Kinetic Medical Products | HTD | Class I | 1989-01-27 |
| K890242 | SCALPEL HANDLE | Kinetic Medical Products | GDZ | Class I | 1989-01-27 |
| K890264 | STRABISMUS SCISSORS | Kinetic Medical Products | LRW | Class I | 1989-01-27 |
| K890217 | MICROSURGICAL KNIVES | Kinetic Medical Products | EMF | Class I | 1989-01-27 |
| K890229 | SURGICAL NEEDLE HOLDERS | Kinetic Medical Products | GDF | Class I | 1989-01-27 |
| K890246 | ARTERY FORCEPS | Kinetic Medical Products | HTD | Class I | 1989-01-27 |
| K890245 | SURGICAL HEMOSTATS | Kinetic Medical Products | HRQ | Class I | 1989-01-27 |
| K890213 | MICROSURGICAL FORCEPS | Kinetic Medical Products | HTD | Class I | 1989-01-27 |
| K890238 | CATHETER FORCEPS | Kinetic Medical Products | HTD | Class I | 1989-01-27 |
| K890234 | SUTURE CLIP REMOVER | Kinetic Medical Products | HTD | Class I | 1989-01-27 |
| K890228 | SURGICAL NEEDLE GUIDE | Kinetic Medical Products | GDF | Class I | 1989-01-27 |
| K885149 | NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE | Hart Enterprises, Inc. | DWO | Class I | 1989-01-26 |
| K890174 | SLT CLMD CONTACT LASER SYSTEM (ADDIT. INDICATION) | Surgical Laser Technologies, Inc. | GEX | Class II | 1989-01-26 |
| K884182 | SURGILASE YAG 100 SURGIPROBES & SURGISCALPEL | Surgilase, Inc. | GEX | Class II | 1989-01-24 |
| K890073 | MODERN LATEX STERILE SURGICAL GLOVES | Modern Rubber Co., Ltd. C/O World Trade Svc. | KGO | Class I | 1989-01-24 |
| K890006 | BAXTER STERILE TOWEL | Healthmed Corp. | KKX | Class II | 1989-01-24 |
| K890119 | BR-S601MU (SURGICAL VIDEO RECORDER) | Victor Co. of Japan, Ltd. C/O Jvc Corp. | FWC | Class I | 1989-01-24 |
| K890090 | DANEK IRRIGATING BURR (DIB) SET | Danek Medical, Inc. | GFF | Class I | 1989-01-24 |
| K890014 | DISPOSABLE COLOR-CUFFS | Instrumed, Inc. | KCY | Class I | 1989-01-24 |
| K890098 | KLEEN TEST O.R. KIT | Kleen Test Products | LRO | Class II | 1989-01-24 |
| K883379 | MODELS 4000/4900/6000/8000/8900 ND:YAG & 1700 CO2 | Heraeus Lasersonics, Inc. | GEX | Class II | 1989-01-24 |
| K890071 | STERILE LACERATION TRAY | Mumtaz I. Malik | LRP | Class I | 1989-01-24 |
| K884440 | TECNOL VARIABLE TENSION BANDAGE | Tecnol New Jersey Wound Care, Inc. | NAD | Class I | 1989-01-17 |
| K885199 | #500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES | Olsen Electrosurgical, Inc. | GEI | Class II | 1989-01-13 |
| K885215 | LINCOLN MILLS HIP HOLDER | Lincoln Mills, Inc. | FWZ | Class I | 1989-01-13 |
| K885200 | 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE | Olsen Electrosurgical, Inc. | GEI | Class II | 1989-01-13 |
| K885181 | (HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2 | Heraeus Lasersonics, Inc. | GEX | Class II | 1989-01-10 |
| K884877 | OCUSHIELDS MASKS | Dioptics | FXX | Class II | 1989-01-10 |
| K884499 | LATEX SURGICAL GLOVES | Yuli Corp., Inc. | KGO | Class I | 1989-01-09 |
| K884334 | GAUZE BANDAGE 1 X 6 YDS. | North Health Care | NAB | Class I | 1989-01-09 |
| K885184 | SHAW SUN SYSTEMS MODEL 2400 | Shaw Sun Systems | FTC | Class II | 1989-01-09 |
| K884335 | GAUZE BANDAGE 4 X 6 YDS. | North Health Care | NAB | Class I | 1989-01-09 |
| K885025 | HOUVA II UVA | National Biological Corp. | FTC | Class II | 1989-01-09 |
| K884333 | GAUZE BANDAGE 2 X 6 YDS. | North Health Care | NAB | Class I | 1989-01-09 |
| K881664 | LATEX SURGICAL GLOVE | Lien Chang Rubber Industrial Co., Ltd. | KGO | Class I | 1989-01-06 |
| K885172 | ADDITIONAL ELECTROSURGICAL GROUND PADS | Conmedcorp | GEI | Class II | 1989-01-06 |
| K884682 | LIVING TECHNOLOGY LASER CONTACT TIPS | Living Technology, Inc. | GEX | Class II | 1989-01-05 |
| K884862 | ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE | Anchor Products Co. | GES | Class I | 1988-12-27 |
| K884641 | BOVAC SMOKE COLLECTOR | Orthopedic Systems, Inc. | GEI | Class II | 1988-12-22 |
| K885042 | SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MD | Sony Medical Electronics Co. | KQM | Class I | 1988-12-22 |
| K883488 | CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL. | Heraeus Lasersonics, Inc. | GEX | Class II | 1988-12-19 |
| K884459 | LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE | Luxar Corp. | GEX | Class II | 1988-12-19 |
| K884876 | S 4 INSTRUMENT STAND | Carl Zeiss, Inc. | FSH | Class I | 1988-12-15 |
| K884929 | OCCUSHIELDS | Dioptics | FXX | Class II | 1988-12-15 |
| K884838 | ALLEN PRONE ARMBOARD | Edgewater Medical Systems, Inc. | BTX | Class I | 1988-12-15 |
| K884928 | FREE ARM(TM) | Faro Medical Technologies, Inc. | FWZ | Class I | 1988-12-15 |
| K884994 | SHARPLAN-MEDILAS 4060N YAG LASER & SERIES 2900 TIP | Sharplan Lasers, Inc. | GEX | Class II | 1988-12-15 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.