Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 53
- Latest Decision
- 1987-09-25
Clearances · page 136 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K873462 | VAN DELLEN ASPIRATOR | Van Dellen, Ltd. | BTA | Class II | 1987-09-25 |
| K873430 | FAC GE1/HI PERF FAC UPR BODY TE2/FULL BODY GA 8-12 | Klafs Sunlight Corp. | FTC | Class II | 1987-09-25 |
| K873493 | NINJA SCALPEL | Primrose Medical, Inc. | GES | Class I | 1987-09-24 |
| K873290 | LACERATION AND INSTRUMENT TRAYS | Advantage Medical Systems, Inc. | LRP | Class I | 1987-09-24 |
| K873478 | SKYTRON MODEL 130 SURGICAL TABLE | Skytron, Div. the Kmw Group, Inc. | FWY | Class I | 1987-09-24 |
| K873277 | MITRAFLEX(TM) WOUND DRESSING | Matrix Medica, Inc. | NAD | Class I | 1987-09-17 |
| K873275 | EXTENSION TABLE 1417 | Stierlen-Maquet AG | JEB | Class I | 1987-09-17 |
| K873273 | ORTHOPAEDIC TABLE 1420 | Stierlen-Maquet AG | JEB | Class I | 1987-09-17 |
| K873274 | PLASTER TABLE 1418 | Stierlen-Maquet AG | JEB | Class I | 1987-09-17 |
| K873276 | EXTENSION DEVICE 1416 | Stierlen-Maquet AG | JEB | Class I | 1987-09-17 |
| K872951 | AMERICAN BRAIN RETRACTOR COVER | American Silk Sutures, Inc. | GET | Class I | 1987-09-16 |
| K873139 | VARUS AND VALGUS LEG HOLDER | Leonard Medical, Inc. | FWZ | Class I | 1987-09-16 |
| K872608 | HEWSON A.C.L. GUIDE SET | Concept, Inc. | KGS | Class I | 1987-09-16 |
| K872988 | TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING | Smith & Nephew, Inc. | NAD | Class I | 1987-09-16 |
| K873434 | CREAT BRAND MALAR IMPLANT | Aesthetech Corp. | LZK | Class II | 1987-09-11 |
| K873475 | MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS | Mcghan Medical Corp. | GEY | Class I | 1987-09-11 |
| K873391 | MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8 | Ormed Mfg., Inc. | GDY | Class I | 1987-09-11 |
| K872589 | ACCESSORY TO LASER EQUIPMENT - SMOKE EVACUATOR | Class, Inc. | GEX | Class II | 1987-09-11 |
| K873439 | LACERATION TRAY | Ulti-Med Intl., Inc. | LRP | Class I | 1987-09-11 |
| K873476 | MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS | Mcghan Medical Corp. | GEY | Class I | 1987-09-11 |
| K873370 | ALLEN MALLEABLE ANESTHESIA SCREEN | Edgewater Medical Equipment Systems | FWZ | Class I | 1987-09-11 |
| K873332 | MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM | American V. Mueller | GCY | Class I | 1987-09-08 |
| K873272 | ENDOSCOPY TABLE 1532 ENDOSTAR | Stierlen-Maquet AG | BWN | Class I | 1987-09-08 |
| K873470 | TEMPLATE | Cox-Uphuff Intl. | FTY | Class I | 1987-09-08 |
| K873124 | ANCHOR BIOPSY NEEDLE | Anchor Products Co. | GAA | Class I | 1987-09-08 |
| K871865 | SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE | Sharplan Lasers, Inc. | LNK | Class II | 1987-09-08 |
| K873142 | PERSONNA DISPOSABLE SCALPEL | American Safety Razor Co. | GES | Class I | 1987-09-04 |
| K872875 | STRETCH GAUZE BANDAGES | Abco Dealers, Inc. | NAD | Class I | 1987-09-04 |
| K873097 | PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS | Ipax, Inc. | GBQ | Class I | 1987-09-04 |
| K873313 | SURGICAL DRAPE | American Medical Technology, Inc. | KKX | Class II | 1987-09-04 |
| K872705 | BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT) | Clinical Technology Corp. | GEI | Class II | 1987-09-01 |
| K873046 | OVONIC COATED SURGICAL SCISSORS | Micrins, Ltd. | LRW | Class I | 1987-08-26 |
| K872630 | ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. | Hgm, Inc. | LNK | Class II | 1987-08-25 |
| K872900 | THE PORTABLE ORDERLY | Edgewater Medical Equipment Systems | FWZ | Class I | 1987-08-21 |
| K872947 | POREX QUALITY PLASTIC SURGERY INSTRUMENTS | Porex Medical | KDG | Class I | 1987-08-21 |
| K871570 | APEX ALPHA VACUUM PUMP | Apex Medical, Inc. | BTA | Class II | 1987-08-18 |
| K873009 | CONCEPT SWITCHING STICK | Concept, Inc. | KGZ | Class I | 1987-08-17 |
| K872214 | COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS | CooperVision, Inc. | GEA | Class I | 1987-08-17 |
| K872991 | MICRINS FORCEPS 2010 | Micrins Surgical, Inc. | GEN | Class I | 1987-08-17 |
| K872990 | MICRINS SURGICAL SCISSOR | Micrins Surgical, Inc. | FZT | Class I | 1987-08-17 |
| K872982 | JOHNSON & JOHNSON ABSORBENT OCCLUSIVE DRESSING | Johnson & Johnson Professionals, Inc. | NAD | Class I | 1987-08-14 |
| K872906 | SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE | American Silk Sutures, Inc. | GEA | Class I | 1987-08-11 |
| K872919 | OMNI-TRACT CORRAL RETRACTOR | Minnesota Scientific, Inc. | GAD | Class I | 1987-08-11 |
| K872319 | LN 100 BREAST MARKER | Instrumentation Industries, Inc. | FTY | Class I | 1987-08-11 |
| K872350 | FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE | Laser Media | LNK | Class II | 1987-08-10 |
| K872532 | AUTO SUTURE STAINLESS STEEL SUTURES* | United States Surgical, A Division of Tyco Healthc | GAO | Class II | 1987-08-05 |
| K872809 | GAUZE CHERRY SPONGE | American Silk Sutures, Inc. | GDY | Class I | 1987-08-04 |
| K872648 | SOLAR GOLD UVA SUN TANNING BED | An-Mar International, Ltd. | FTC | Class II | 1987-08-04 |
| K872787 | MODIFIED CURLCATH | Quinton, Inc. | GBQ | Class I | 1987-08-04 |
| K872797 | NON-SKID SHOE COVERS | Abco Dealers, Inc. | FXP | Class I | 1987-08-04 |
| K872031 | UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM | Laser Media | LNK | Class II | 1987-08-04 |
| K872807 | NON-WOVEN TRACHEOTOMY SPONGE | American Silk Sutures, Inc. | GDY | Class I | 1987-08-04 |
| K872519 | STERILIZED OMNI GEL | Echo Ultrasound | JOT | Class II | 1987-08-03 |
| K872620 | SOLOS EYESITE DRAPES | Solos Ophthalmology | HMT | Class II | 1987-07-31 |
| K872758 | THEATRE GOWNS | Smith & Nephew, Inc. | FYA | Class II | 1987-07-31 |
| K872597 | FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE | Dianon Systems, Inc. | DWO | Class I | 1987-07-28 |
| K872757 | OPSITE SPECIALITY DRAPES | Smith & Nephew, Inc. | KKX | Class II | 1987-07-28 |
| K871619 | LPM-1 (LASER POWER METER) | Bio-Tek Instruments, Inc. | GEX | Class II | 1987-07-28 |
| K872706 | PANOSOL 2000 624-616 | National Biological Corp. | FTC | Class II | 1987-07-27 |
| K872651 | PANOSOL 2000 624-414 | National Biological Corp. | FTC | Class II | 1987-07-27 |
| K872707 | PANOSOL 2000 624-404 | National Biological Corp. | FTC | Class II | 1987-07-27 |
| K872649 | HAND/FOOT UVA/UVB 624-224 | National Biological Corp. | FTC | Class II | 1987-07-27 |
| K872650 | PANOSOL 2000 624-604 | National Biological Corp. | FTC | Class II | 1987-07-27 |
| K872117 | DEXTRANOMER | Interworld, Inc. | KOZ | Class I | 1987-07-24 |
| K872605 | HAND/FOOT UVA 624-218 | National Biological Corp. | FTC | Class II | 1987-07-24 |
| K872604 | HAND/FOOT 624-208 | National Biological Corp. | FTC | Class II | 1987-07-24 |
| K872460 | AN3000 MAHONEY DRAIN | H.W. Andersen Products, Inc. | GBS | Class I | 1987-07-23 |
| K872796 | ADDITIONS TO WSL NITROSPRAY CRYOSURGICAL UNITS | Tower Mfg. Co., Inc. | GEH | Class II | 1987-07-23 |
| K872490 | 1.1 SCREWDRIVERS | Micro-Aire Surgical Instruments, Inc. | LRZ | Class I | 1987-07-23 |
| K872388 | NAIL SET | Med-Tool, Inc. | LRY | Class I | 1987-07-23 |
| K871558 | DENTAL FACE MASKS, POLYESTER | Carl Parker Associates, Inc. | FXX | Class II | 1987-07-22 |
| K871206 | LUMENX MODEL GAT-577 PHOTOCOAGU. PULSED DYE LASER | Phase-R Corp. | GEX | Class II | 1987-07-22 |
| K872550 | 1.1 COUPLERS AND 1.2 ADAPTERS | Micro-Aire Surgical Instruments, Inc. | HSZ | Class I | 1987-07-21 |
| K872459 | AN3100 MULHOLLAND DRAIN | H.W. Andersen Products, Inc. | GBS | Class I | 1987-07-21 |
| K872661 | RGB CAMERA SYSTEM | Aspen Laboratories, Inc. | FWF | Class I | 1987-07-21 |
| K872457 | AN3500 WORTH DRAIN | H.W. Andersen Products, Inc. | GBS | Class I | 1987-07-21 |
| K872714 | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY | Roseburg SA | GBI | Class I | 1987-07-21 |
| K872491 | 1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS | Micro-Aire Surgical Instruments, Inc. | GEG | Class I | 1987-07-16 |
| K872385 | VICE OR BENCH VICE | Med-Tool, Inc. | LSA | Class I | 1987-07-16 |
| K872387 | STANDARD SCREW DRIVER | Med-Tool, Inc. | LRZ | Class I | 1987-07-16 |
| K871565 | ULTRASOUND TRANSDUCER GEL, STERILE | Amedic USA | JOT | Class II | 1987-07-15 |
| K871413 | CIVCO STEPPER | CIVCO Medical Instruments Co., Inc. | FZX | Class I | 1987-07-14 |
| K872069 | KONTOUR ULTRA SOFT SPONGE #SS144.50 | Winfield Laboratories, Inc. | NAD | Class I | 1987-07-14 |
| K872011 | PORT ACCESS KITS | The Jarid Group, Inc. | LRO | Class II | 1987-07-13 |
| K871503 | BIOPSY NEEDLE GUIDE KIT, STERILE | Amedic USA | FZX | Class I | 1987-07-10 |
| K871458 | SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW | Fraass Survival Systems, Inc. | KDD | Class I | 1987-07-09 |
| K871514 | SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOID | Medical Energy, Inc. | LNK | Class II | 1987-07-09 |
| K871437 | SURVIVAL KIT, INDIVIDUAL | Fraass Survival Systems, Inc. | LRO | Class II | 1987-07-09 |
| K871515 | SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING | Medical Energy, Inc. | LNK | Class II | 1987-07-09 |
| K871434 | MEDICAL PACKET, INDIVIDUAL SURVIVAL KIT, AIRMAN'S | Fraass Survival Systems, Inc. | LRO | Class II | 1987-07-09 |
| K871516 | SL-100 ND:YAG LASER FOR UROLOGIC SURGERY | Medical Energy, Inc. | LNK | Class II | 1987-07-09 |
| K871513 | SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI | Medical Energy, Inc. | LNK | Class II | 1987-07-09 |
| K871873 | CLOSED CHEST DRAINAGE SET | Gish Biomedical, Inc. | LRO | Class II | 1987-07-09 |
| K872395 | CK 1600 SERIES, TOWELS | Currie Medical Specialties, Inc. | KKX | Class II | 1987-07-02 |
| K872475 | SURGICAL BUR | Tava Surgical Instruments | GFF | Class I | 1987-07-02 |
| K872384 | SIDE CUTTING PARALLEL ACTION PLIERS | Med-Tool, Inc. | HTC | Class I | 1987-07-02 |
| K872386 | C CLAMP | Med-Tool, Inc. | HXD | Class I | 1987-07-02 |
| K872099 | BIOFILM TRANS. ISLAND, ISLAND ULCER & WOUND DRESS. | The Bfgoodrich Co. | NAD | Class I | 1987-06-30 |
| K865038 | SURGISTEEL | Sutures , Ltd. | GAQ | Class II | 1987-06-30 |
| K872101 | BIOFILM TRANS. POUCH ULCER & WOUND DRESSING | The Bfgoodrich Co. | NAD | Class I | 1987-06-30 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.