Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 49
- Latest Decision
- 1980-04-28
Clearances · page 158 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K800417 | ADT PTC PRO. TRAY W/(SKINNY CHIBA) NEEDL | A.D.T. Lab Industries | GAA | Class I | 1980-04-28 |
| K800410 | ADT BONE MARROW BIOPSY-ASPIRATION TRAY | A.D.T. Lab Industries | GAA | Class I | 1980-04-28 |
| K800411 | ASPIRATION TRAY W/FERRIS DISP. ILLINOIS | A.D.T. Lab Industries | GAA | Class I | 1980-04-28 |
| K800412 | ROSENTHAL NEEDLE (DISP.) ADT BONE MARROW | A.D.T. Lab Industries | GAA | Class I | 1980-04-28 |
| K800408 | ADT BONE MAR. BIO/ASP. TRAY W/NEEDLE | A.D.T. Lab Industries | GAA | Class I | 1980-04-28 |
| K800409 | ADT BONE MARROW BIOPSY ASPIRATION TRAY | A.D.T. Lab Industries | GAA | Class I | 1980-04-28 |
| K800404 | MEDSPEC OPERATIVE OPTHALMIC KIT | Medi-Spec | HMP | Class I | 1980-04-24 |
| K800557 | DISPOSABLE PRE-GELLED ELECTROSURGICAL | Vxtra Corp. | GEI | Class II | 1980-04-21 |
| K800511 | SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP | American Convertors Div., American Pharmaseal | FYF | Class I | 1980-04-16 |
| K800543 | SNYDER HYSTERECTOMY Y TUBE KIT | Snyder Laboratories, Inc. | GCY | Class I | 1980-04-16 |
| K800577 | SNYDER HEMOVAC TM VENTED WOUND KIT | Snyder Laboratories, Inc. | GCY | Class I | 1980-04-16 |
| K800578 | SURGIVAC TM | Snyder Laboratories, Inc. | GCY | Class I | 1980-04-16 |
| K800528 | SHIELD PERFECT FIT; DURA-FIT, DISPOS. | American Convertors Div., American Pharmaseal | FXP | Class I | 1980-04-16 |
| K800647 | NORSEN DEBRIDER | Medline Industries, Inc. | GEN | Class I | 1980-04-16 |
| K800535 | 3M DISPOSABLE SKIN STAPLER | 3M Company | GDT | Class I | 1980-04-04 |
| K800335 | KRYMED LIQUID NITROGEN CRYOJET | Cryomedics, Inc. | GEH | Class II | 1980-04-04 |
| K800581 | TLS TM SURGICAL DRAINAGE SYSTEM | Glasrock Products, Inc. | GCY | Class I | 1980-04-04 |
| K800542 | 100 ML SNYDER HEMOVAC | Snyder Laboratories, Inc. | GCY | Class I | 1980-04-02 |
| K800597 | REUSABLE HAND-TROL | Aspen Laboratories, Inc. | GEI | Class II | 1980-04-02 |
| K800015 | AXIOM VESSEL LOOPS | Axiom Medical, Inc. | KDC | Class I | 1980-03-25 |
| K800423 | ADT NERVE BLOCK TRAY(DISP.) | A.D.T. Lab Industries | GAA | Class I | 1980-03-25 |
| K800413 | FERRIS MODIFIED DISP. IL STERNAL-ILIAC | A.D.T. Lab Industries | GAA | Class I | 1980-03-25 |
| K800421 | ADT PERITONEAL LAVAGE TRAY (DISP.) | A.D.T. Lab Industries | GAA | Class I | 1980-03-25 |
| K800415 | ADT MENGHINI TYPE SOFT TISSUE BIOPSY | A.D.T. Lab Industries | GAA | Class I | 1980-03-25 |
| K800552 | ZEISS DISPOSABLE, STERILE SURGICAL DRAPE | Carl Zeiss, Inc. | KKX | Class II | 1980-03-20 |
| K800315 | DUAL MPC CHARGER | Black & Decker(Tm) | KIJ | Class I | 1980-03-19 |
| K800314 | POWER PACK | Black & Decker(Tm) | KIJ | Class I | 1980-03-19 |
| K800435 | HEMOSTATIC/TUBE OCCLUDING FORCEPS | Dravon Medical, Inc. | GEN | Class I | 1980-03-12 |
| K800406 | FERRIS BONE MARROW BIOPSY-ASPIR. NEEDLE | A.D.T. Lab Industries | GDM | Class I | 1980-03-12 |
| K800317 | DAVOL EMS ADAPTER, CAT. NO. 13-7664 | Electrocaine Medical System | GEI | Class II | 1980-03-12 |
| K800490 | STERILE DRESSING PACK | Medi-Spec | KKX | Class II | 1980-03-12 |
| K800422 | ADT MINI PERITONEAL LAVAGE KIT | A.D.T. Lab Industries | GBW | Class I | 1980-03-12 |
| K800281 | MEDSPEC PACKING GAUZE | Medspec Corp. | GDY | Class I | 1980-03-12 |
| K800407 | FERRIS BONE MARROW -NEEDLE-(DISPOSABLE) | A.D.T. Lab Industries | GAA | Class I | 1980-03-12 |
| K800367 | MICRESURGICAL TRAY, SM.,MED., & LG. | Edward Weck, Inc. | FSM | Class I | 1980-03-10 |
| K800318 | DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI | Edward Weck, Inc. | HBT | Class I | 1980-03-10 |
| K800331 | SURGITEK FOERSTER FACE LIFT DRAIN | Medical Engineering Corp. | GCY | Class I | 1980-03-05 |
| K800160 | SUN-TANNING BOOTHS | World Wide Sun Systems, Inc. | FTC | Class II | 1980-03-03 |
| K800311 | 450 DRILL/800 DRILL | Black & Decker(Tm) | KIJ | Class I | 1980-02-22 |
| K800312 | 150 DRIVER/REAMER | Black & Decker(Tm) | KIJ | Class I | 1980-02-22 |
| K800313 | SAGITTAL SAW | Black & Decker(Tm) | KIJ | Class I | 1980-02-22 |
| K792500 | UVB LIGHT BOX - UVB LIGHT BOOTH | Sun Shanty, Inc. | FTC | Class II | 1980-02-19 |
| K800273 | ACUFEX FORCEPS | Acufex Microsurgical, Inc. | HTD | Class I | 1980-02-19 |
| K800152 | SURGIKOS NEUTRALON BR. SURGEON'S GLOVE | Surgikos, Inc. | KGO | Class I | 1980-02-19 |
| K800275 | CEBOTOME DRILL | American Sterilizer Co. | HSZ | Class I | 1980-02-19 |
| K800177 | I.M. BLADES | Instrument Makar, Inc. | GDX | Class I | 1980-02-11 |
| K800022 | MODEL 807 SUCTION CAUTERY FINGER TIP | Malibu Laboratories | GEI | Class II | 1980-02-11 |
| K800153 | EXTEMP/EXTEMP-V | Pharma-Filter, Inc. | GAA | Class I | 1980-02-06 |
| K800118 | CHICK SURGICAL TABLE | Warner-Lambert Co. | FWY | Class I | 1980-02-05 |
| K792418 | SHARPLAN 743, CO2 LASER SURGICAL SYSTEM | Laser Industries , Ltd. | GEX | Class II | 1980-02-05 |
| K800124 | ULTRASOFT GOWN | Mars Mfg Co. | FYA | Class II | 1980-02-05 |
| K800074 | VESSEL OCCLUDER | Cordis Corp. | GDJ | Class I | 1980-01-28 |
| K800081 | DAVOL/ABAMSON SILICONE SUMP DRAIN | Davol, Inc. | GCY | Class I | 1980-01-28 |
| K800058 | ANAGO ELECTRO SURGICAL TIP CLEANER | Anago, Inc. | GEC | Class I | 1980-01-28 |
| K800079 | HEMOCLIP SURGICAL OCCLUDING CLIP | Edward Weck, Inc. | FZP | Class II | 1980-01-28 |
| K800103 | SURGICAL STITCH CUTTER | Macon & Co., Inc. | FZT | Class I | 1980-01-28 |
| K800102 | STANFORD STERILE LAP SPONGES | Lukens Corp. | GDY | Class I | 1980-01-28 |
| K800014 | DOW CORNING/W RIGHT WOUND DRAINAGE SYS | Dow Corning Corp. Healthcare Industries Materials | GCY | Class I | 1980-01-17 |
| K792630 | STERILIZATION PROCESS/X-RAY DETECT. SPG | Procter & Gamble Mfg. Co. | GDY | Class I | 1980-01-11 |
| K792622 | STERILIZATION PROCESS /USE GOWNS | Procter & Gamble Mfg. Co. | FYA | Class II | 1980-01-11 |
| K792621 | STERILIZATION PROCESS CHANGE BOUNDARY | Procter & Gamble Mfg. Co. | KKX | Class II | 1980-01-11 |
| K792592 | AMBU UNIVERSAL SUCTION PUMP | Narco Air-Shields | JCX | Class II | 1980-01-11 |
| K792623 | STERILIZATION PROCESS/ABSORBENT TOWEL | Procter & Gamble Mfg. Co. | KKX | Class II | 1980-01-11 |
| K792600 | MODEL III HANDSWITCH | Sara Dan, Inc. | GEI | Class II | 1980-01-10 |
| K792569 | OPERATING TABLES & AMPLINOX 03 | Ets Rene Marzet | BWN | Class I | 1980-01-04 |
| K791868 | OXIMETRIX SHAW HEMOSTATIC SURG. SYS. | Oximetrix, Inc. | GEI | Class II | 1980-01-04 |
| K791977 | PSORALITE MARK I | Paul B. Elder Co. | KGL | Class II | 1979-12-28 |
| K792353 | INTRA-ARTICULATED EDGER-PLANER SYSTEM | Richard Wolf Medical Instruments Corp. | HWE | Class I | 1979-12-27 |
| K792272 | DEXIDE DIS. SUR. SCRUB SPONGE W/PARACHLO | Dexide, Inc. | GEC | Class I | 1979-12-27 |
| K792468 | FEEDING TUBE PLACEMENT STYLET | Biosearch Medical Products, Inc. | FZX | Class I | 1979-12-27 |
| K792494 | CATHETERIZATION FORCEP | C. Intl. | GEN | Class I | 1979-12-20 |
| K792471 | STANFORD STERILE LAP SPONGES | Lukens Corp. | GDY | Class I | 1979-12-20 |
| K791895 | ACCESSORIES FOR SYS. 400 CO2 SURG. LASER | Coherent Medical Division | GEX | Class II | 1979-12-20 |
| K792372 | IPOS BREAST PROSTHESIS | Ipos KG | GBI | Class I | 1979-12-19 |
| K791843 | PONCY PAK | Poncy, Inc. | KGO | Class I | 1979-12-19 |
| K792343 | DIATHERMIC SNARE (CRESENT TYPE) | Mill-Rose Laboratory | GEI | Class II | 1979-12-18 |
| K792316 | TROTEX II SCREW NEEDLE BIOPSY INSTR. SET | Ursus Konsult AB | GEE | Class I | 1979-12-18 |
| K792357 | STERILE IMPERVIOUS ORTHOPEDIC STOCKIN | Alba-Waldensian, Inc. | KKX | Class II | 1979-12-18 |
| K792176 | DRAPE, MICROSCOPE | Chris Co., Inc. | KKX | Class II | 1979-12-10 |
| K792271 | DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE | Dexide, Inc. | GEC | Class I | 1979-12-10 |
| K792242 | SURGI-PREP PAINT STICK #1 WET PACK | Gard Research Corp. | GEC | Class I | 1979-12-10 |
| K792365 | BIPOLAR FORCEPS | Concept, Inc. | JOS | Class II | 1979-12-10 |
| K792273 | DEXIDE DIS. PREP SPONGE W/IDEX PATIENT P | Dexide, Inc. | GEC | Class I | 1979-12-10 |
| K792150 | MODEL 808 ADAPTER | Malibu Laboratories | GEI | Class II | 1979-12-06 |
| K792378 | HEMOSPENSER CARTRIDGE CAT. NO. 523500- | Edward Weck, Inc. | GDO | Class I | 1979-12-06 |
| K792147 | ARM SHIELD FOR ANESTHESIA | Medical Innovations Corp. | BTX | Class I | 1979-12-06 |
| K792256 | KEITHLEY CLAMP | Keithley Development Co. | EYR | Class I | 1979-12-06 |
| K792332 | DAVOL/SIMON DERMATOME | Davol, Inc. | GFD | Class I | 1979-12-06 |
| K792145 | AUTOMATIC RETRACTOR HOLDERS | Automated Medical Products, Inc. | GAD | Class I | 1979-12-05 |
| K792309 | CASTROVIEJO VASCULAR NEEDLEHOLDER 538425 | Edward Weck, Inc. | GEN | Class I | 1979-11-30 |
| K792315 | A.D.E. ASPEN DISPERSIVE ELECTRODE | Zimmer, Inc. | GEI | Class II | 1979-11-27 |
| K792281 | USHER'S MARLEX TUBULAR MESH | Davol, Inc. | FTL | Class II | 1979-11-27 |
| K791726 | HYDROGEL-PREP | Spenco Medical Corp. | NAB | Class I | 1979-11-20 |
| K792044 | SAFE RETURN COT. #9675 & CONNECTOR ADAPT | Concept, Inc. | GEI | Class II | 1979-11-16 |
| K792083 | HAAG-STREIT SLIT LAMP 900 | Lumenis, Inc. | HRM | Class I | 1979-11-16 |
| K792100 | GRASPING FORCEP (W/FOUR PRONGS) | Eder Instrument Co, Inc. | GEN | Class I | 1979-11-13 |
| K792004 | HEWSON LIGAMENT BUTTON | Richard'S Medical Equip., Inc. | KGS | Class I | 1979-11-05 |
| K792106 | CONPHAR O.R. HEAD COVER-STERILE | Conphar, Inc. | FYI | Class I | 1979-11-05 |
| K792110 | CONPHAR FACE MASK-STERILE | Conphar, Inc. | FXX | Class II | 1979-11-05 |
| K791870 | DISPOSABLE SPECIALITY SPONGES | Carwild Corp. | GDI | Class I | 1979-11-05 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.