Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 41
- Latest Decision
- 1990-05-09
Clearances · page 125 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K900945 | LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING | Palex Medical, Inc. | KKX | Class II | 1990-05-09 |
| K901145 | NDM SWITCHPEN HOLSTER | Ndm Corp. | GEI | Class II | 1990-05-09 |
| K901742 | INAMED SMALL DRAIN SYSTEM | Inamed Development Co. | GCY | Class I | 1990-05-07 |
| K901764 | INAMED CONVERTIBLE DRAIN SYSTEM | Inamed Development Co. | GCY | Class I | 1990-05-07 |
| K900633 | DISP. ELECTROSURGERY PENCIL, HAND CONTROL | Medical/Surgical Specialties, Ltd. | GEI | Class II | 1990-05-07 |
| K896946 | COATED NOVAFIL, POLYBUTESTER, MESH | American Cyanamid Co. | FTM | Class II | 1990-05-07 |
| K894828 | HPI ORTHO SURGEONS' GLOVE | Tillotson Rubber Co., Inc. | KGO | Class I | 1990-05-07 |
| K900767 | B-300 COMBINATION SWITCHING DISPOSABLE HANDPIECE | Beacon Laboratories, Inc. | GEI | Class II | 1990-05-04 |
| K900630 | MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG | Heraeus Lasersonics, Inc. | GEX | Class II | 1990-05-04 |
| K900539 | MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL | Sunrise Technologies, Inc. | GEX | Class II | 1990-05-03 |
| K901008 | HEXASCAN HANDPIECE | Lihtan Technologies, Inc. | GEX | Class II | 1990-05-03 |
| K900751 | HERAEUS LASERSONICS CO2 WAVEGUIDE DELIVERY SYSTEM | Heraeus Lasersonics, Inc. | GEX | Class II | 1990-05-03 |
| K900903 | KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE | Milex Products, Inc. | GDF | Class I | 1990-05-03 |
| K900566 | RICHARD-ALLAN VESSEL LOOPS | Richard-Allan Medical Ind., Inc. | KDC | Class I | 1990-05-03 |
| K900511 | I.C. MEDICAL ADJUSTABLE DIRECT COUPLER | I.C Medical, Inc. | GEX | Class II | 1990-05-01 |
| K901662 | ANATOMICAL MALAR IMPLANT | Implantech Associates, Inc. | LZK | Class II | 1990-05-01 |
| K900570 | SURGILASE YAG 100 IN ORTHOPEDIC SURGERY | Surgilase, Inc. | GEX | Class II | 1990-05-01 |
| K901211 | SURGILASE SL50 SURGICAL LASER SYSTEM | Surgilase, Inc. | GEX | Class II | 1990-04-26 |
| K901324 | U.V. SUNLAMP 95UF-II | Light Sources, Inc. | FTC | Class II | 1990-04-26 |
| K901227 | SURGILASE CO2 SURGICAL LASER SYSTEMS MODEL SL120 | Surgilase, Inc. | GEX | Class II | 1990-04-26 |
| K901035 | FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE | Cuda Products Co. | FST | Class II | 1990-04-23 |
| K900374 | ADAIR/VERESS NEEDLE INTRODUCER SET | Medical Dynamics, Inc. | GCB | Class I | 1990-04-20 |
| K900486 | APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER | Davis & Geck, Inc. | GDT | Class I | 1990-04-20 |
| K900954 | GS-5200 HOOK SUCTION/COAGULATOR, 5MM | Solos Endoscopy, Inc. | GEI | Class II | 1990-04-18 |
| K900951 | GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP | Solos Endoscopy, Inc. | GEN | Class I | 1990-04-18 |
| K900960 | GS-1500 CLAW FORCEP, 10MM | Solos Endoscopy, Inc. | GEN | Class I | 1990-04-18 |
| K900957 | GS-2100 HOOK SUTURE SCISSOR, 5MM | Solos Endoscopy, Inc. | LRW | Class I | 1990-04-18 |
| K900948 | GS-1002 GRASPING FORCEP, 5MM WITH RATCHET | Solos Endoscopy, Inc. | GEN | Class I | 1990-04-18 |
| K900950 | GS-2000 MICRO SCISSOR, CURVED LEFT, 5MM | Solos Endoscopy, Inc. | LRW | Class I | 1990-04-18 |
| K900959 | GS-1400 TOOTHED DISSECTING FORCEP, 5MM, INSULATED | Solos Endoscopy, Inc. | GEJ | Class I | 1990-04-18 |
| K900953 | GS-5000 SPATULA SUCTION/COAGULATOR, 5MM | Solos Endoscopy, Inc. | GEI | Class II | 1990-04-18 |
| K900947 | GS-1000 GRASPING FORCEP, 5MM, INSULATED | Solos Endoscopy, Inc. | GEI | Class II | 1990-04-18 |
| K900949 | GS-1100 MICRO DISSECTING FORCEP, 5MM, INSULATED | Solos Endoscopy, Inc. | GEI | Class II | 1990-04-18 |
| K900956 | GS-7100 CHOLANGIOGRAM CLAMP, 5MM | Solos Endoscopy, Inc. | GDJ | Class I | 1990-04-18 |
| K900958 | GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MM | Solos Endoscopy, Inc. | GEJ | Class I | 1990-04-18 |
| K900952 | GS-1200 GRASPING/EXTRACTING FORCEP, 10MM | Solos Endoscopy, Inc. | GEN | Class I | 1990-04-18 |
| K900669 | HYPO-ALLERGENIC SURGICAL GLOVES | Modern Rubber Industrial Co., Ltd. | KGO | Class I | 1990-04-16 |
| K897050 | WILSON-COOK LUNG BIOPSY NEEDLE | Wilson-Cook Medical, Inc. | GAA | Class I | 1990-04-16 |
| K900128 | CL-OPE CONTACT LASER SYSTEM | Lca, Inc. | GEX | Class II | 1990-04-16 |
| K900069 | MODIFIED PGL ABSORBABLE STAPLE* | United States Surgical, A Division of Tyco Healthc | GDG | Class I | 1990-04-16 |
| K901541 | LASER LAPAROSCOPIC CHOLECYSTECTOMY | Surgical Laser Technologies, Inc. | GEX | Class II | 1990-04-13 |
| K901021 | F300 SERIES CONTACT FIBER HANDPIECES | Hgm Medical Laser Systems, Inc. | GEX | Class II | 1990-04-13 |
| K900347 | BIRTCHER FOOTCONTROLLED SUCTION COAGULATOR | Birtcher Electro Medical Systems | GEI | Class II | 1990-04-10 |
| K900376 | HAND SURGERY AND IRRIGATION TRAY (MODEL 3625) | Pmt Corp. | FSM | Class I | 1990-04-10 |
| K900345 | SHARPLAN ND:YAG LASERS FOR ENT AND NECK SURGERY | Sharplan Lasers, Inc. | GEX | Class II | 1990-04-10 |
| K900533 | DISPOSABLE BIPOLAR COAGULATING FORCEPS | Kirwan Surgical Products, Inc. | GEI | Class II | 1990-04-09 |
| K901107 | MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC | United States Surgical, A Division of Tyco Healthc | GDJ | Class I | 1990-04-09 |
| K895945 | KTP/532 SURGICAL LASER SYSTEM W/KTP/YAG MODULE | Laserscope | GEX | Class II | 1990-04-09 |
| K900253 | MODEL 20-CH CARBON DIOXIDE LASER W/ADD'L USES | Pfizer Laser Systems | GEX | Class II | 1990-04-05 |
| K894087 | SURGEON'S GLOVES | Shangrila Latex Industries Pvt. , Ltd. | KGO | Class I | 1990-04-04 |
| K900346 | SHARPLAN ND:YAG LASER LAPAROSCOPIC CHOLECYSTECTOMY | Sharplan Lasers, Inc. | GEX | Class II | 1990-04-04 |
| K901248 | ABC HANDPIECE ADAPTER | Beacon Laboratories, Inc. | HAM | Class II | 1990-04-03 |
| K901359 | VITAL SURGICAL GLOVES | Mastervest Corp. Sdn Bhd. | KGO | Class I | 1990-04-03 |
| K895347 | MICRORUPTOR III SYSTEM, CW ND: YAG LASER COMPONENT | Lasag Medical Lasers | GEX | Class II | 1990-04-02 |
| K901108 | FIBERLUME | Burton | HBI | Class II | 1990-03-28 |
| K900649 | FLUORESCENT T12 UVA LAMP | Light Sources, Inc. | FTC | Class II | 1990-03-28 |
| K900592 | SHARPLAN MODEL 1055 SEALED CO2 SURGICAL LASER | Sharplan Lasers, Inc. | GEX | Class II | 1990-03-27 |
| K900693 | U.V. SUNLAMP (U.V. LIGHT, DERMATOLOGIC) | Light Sources, Inc. | FTC | Class II | 1990-03-27 |
| K900714 | ZZIPP INSTANT BOVIE CLEANER | Grieshaber & Co. | GEI | Class II | 1990-03-27 |
| K900166 | NIDEK, INC. MODELS YC-1100 OPHTHALMIC LASERS | Nidek, Inc. | GEX | Class II | 1990-03-27 |
| K900629 | BERNSCO LUER NEEDLER ADAPTOR | Bernsco Surgical Supply, Inc. | GEI | Class II | 1990-03-22 |
| K900076 | SHARPLAN FLEXIBLE CO2 SURGICAL LASER APPLICATOR | Sharplan Lasers, Inc. | GEX | Class II | 1990-03-22 |
| K900463 | LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS | Ximed Medical Systems | GEX | Class II | 1990-03-22 |
| K900165 | NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM | Nidek, Inc. | GEX | Class II | 1990-03-22 |
| K900138 | MOTECH TITANIUM SURGICAL MESH | Biedermann Motech GmbH | EZX | Class II | 1990-03-20 |
| K900122 | AUTO SUTURE LATCHLESS ABSORBABLE HEMOSTATIC CLIP* | United States Surgical, A Division of Tyco Healthc | FZP | Class II | 1990-03-20 |
| K901154 | MICROTEK'S SURGICAL LAMP HANDLE & COVER | Microbio-Medics, Inc. | FTA | Class II | 1990-03-20 |
| K900985 | SURGEONS' GLOVES W/HYPOALLERGENICITY CLAIMS | Productes Del Latex, S.A. | KGO | Class I | 1990-03-20 |
| K900066 | FLEXIGUIDE(TM) CO2 LASER HOLLOW FLEXIBLE FIBER | Luxar Corp. | GEX | Class II | 1990-03-19 |
| K900153 | SHARPLAN ND:YAG DISPOSABLE FIBER DELIVERY SYSTEM | Sharplan Lasers, Inc. | GEX | Class II | 1990-03-19 |
| K900211 | SKYTRON UNIVERSE SERIES SURGICAL LIGHTS | Skytron, Div. the Kmw Group, Inc. | FSY | Class II | 1990-03-19 |
| K894610 | CUSTOM TRAYS, KITS | L H M Ent., Inc. | FSM | Class I | 1990-03-15 |
| K900104 | TCPM II TOURNIQUET CUFF PRESSURE MONITOR | Electromedics, Inc. | KCY | Class I | 1990-03-15 |
| K900296 | SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES | P.T. Latexindo Prautama | KGO | Class I | 1990-03-14 |
| K900195 | MODIFIED GORE-TEX SURGICAL TAPE | W. L. Gore & Associates, Inc. | MCA | Class II | 1990-03-13 |
| K900691 | BIODYNE INSTRUMENT WIPES | Bio-Dyne, Inc. | GEC | Class I | 1990-03-08 |
| K900088 | MASKS SURGICAL DENTAL | Kab Gloves Unltd. | FXX | Class II | 1990-03-08 |
| K896675 | STERLING STYLE 90 SURGICAL GLOVES | Steril Rubber Sdn. Bhd. | KGO | Class I | 1990-03-08 |
| K894478 | UHMWPE SURGICAL MESH | Biomet, Inc. | KKY | Class II | 1990-03-08 |
| K896939 | DISPOSABLE FIBER OPTIC DELIVERY SYSTEM FOR ND:YAG | Fiber Delivery Concepts, Inc. | GEX | Class II | 1990-03-08 |
| K900462 | OSTEONICS CEMENT RESTRICTOR | Osteonics Corp. | JDK | Class II | 1990-03-06 |
| K892912 | MODEL JM-1 CO2 LASER | L.A.S.E.R., Inc. | GEX | Class II | 1990-03-06 |
| K900077 | SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEM | Sharplan Lasers, Inc. | GEX | Class II | 1990-03-06 |
| K900310 | REPEL SURGICAL GLOVE LINERS | Depuy-Raynham | LYU | Class I | 1990-03-01 |
| K900392 | CENTERING PLUG | Allo Pro Corp. | LZN | Class II | 1990-03-01 |
| K900405 | SCHOLTEN FRAME | Scholten Surgical Instruments, Inc. | JEB | Class I | 1990-03-01 |
| K900266 | STERILE CARBON STEEL SURGICAL BLADE | Rahn Laboratories | GES | Class I | 1990-03-01 |
| K896676 | KEY VASCULAR LOOPS | Key Surgical, Inc. | KDC | Class I | 1990-02-27 |
| K896193 | TECNOL LAZER(TM) SURGICAL MASK | Tecnol New Jersey Wound Care, Inc. | FXX | Class II | 1990-02-27 |
| K900129 | MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER* | United States Surgical, A Division of Tyco Healthc | GDW | Class II | 1990-02-27 |
| K895656 | ACCU-BEAM WAVEGUIDE | Tti Medical | GEX | Class II | 1990-02-22 |
| K897157 | OPTILASE YAG MODEL 1000 ACV SURGICAL LASER SYSTEM | Trimedyne, Inc. | GEX | Class II | 1990-02-22 |
| K895230 | STERILE SURGEON'S GLOVES (C T R GLOVES) | Tan D. W. Trading Co., Inc. | KGO | Class I | 1990-02-22 |
| K896961 | HALUX EXLITE MINOR SURGERY LIGHT | Jedmed Instrument Co. | GBC | Class II | 1990-02-22 |
| K897156 | HYDRASORB(TM) | Avitar, Inc. | NAD | Class I | 1990-02-21 |
| K900290 | SKYTRON MODEL 1100 AND MODEL 142 | Skytron, Div. the Kmw Group, Inc. | JEA | Class I | 1990-02-20 |
| K895654 | SORBEX(TM) SOFT SPONGE | Fountain Pharmaceuticals, Inc. | NAD | Class I | 1990-02-20 |
| K897099 | MODEL 2800 ND:YAG OPHTHALMIC LASER | Alcon Surgical, Inc. | GEX | Class II | 1990-02-16 |
| K896935 | CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE | Baxter Healthcare Corp | FYA | Class II | 1990-02-16 |
| K896762 | SHARPLAN ND:YAG LASER FOR ARTHROSCOPY/MENISCECTOMY | Sharplan Lasers, Inc. | GEX | Class II | 1990-02-16 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.