Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 49
- Latest Decision
- 1985-06-20
Clearances · page 144 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K851801 | 69-120 TO 69-132 VARIOUS NAIL SCISSORS | Artiberia | LRW | Class I | 1985-06-20 |
| K851787 | 27-100 TO 29-130 VARIOUS BONE SAWS-CHARRIERE, SATT | Artiberia | GDR | Class I | 1985-06-20 |
| K851793 | 39-260 TO 39-299 VARIOUS FOREIGN BODY FORCEPS | Artiberia | GEN | Class I | 1985-06-20 |
| K851789 | 29-200 TO 29-230 VARIOUS BONE MALLETS(WIHIGER, DOY | Artiberia | GFJ | Class I | 1985-06-20 |
| K851772 | 17-100,17-272 VARIOUS HAEMOSTATIC FORCEPS | Artiberia | GEN | Class I | 1985-06-20 |
| K851776 | 21-450 GELPI RETRACTOR | Artiberia | GAD | Class I | 1985-06-20 |
| K851750 | 7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7 | Artiberia | GDZ | Class I | 1985-06-20 |
| K851770 | VARIOUS DRESSING TISSUE FROCEPS(GILLIES, JEANS, RA | Artiberia | HTD | Class I | 1985-06-20 |
| K851771 | 15-490 TO 15-520 VARIOUS SPLINTER FORCEPS PEET, ST | Artiberia | GEN | Class I | 1985-06-20 |
| K851796 | 51-210 TO 51-352 VARIOUS INTEST FOR CALLIS, LOCKWO | Artiberia | GEN | Class I | 1985-06-20 |
| K851788 | 29-140 TO 29-196 VARIOUS BONE CHISELS (OSTEOTOMES, | Artiberia | FZO | Class I | 1985-06-20 |
| K851751 | 7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1 | Artiberia | GDX | Class I | 1985-06-20 |
| K851781 | 25-420 TO 25-436 VARIOUS TYPES OF SUTURE NEEDLES | Artiberia | GDL | Class I | 1985-06-20 |
| K851773 | 17-280,17-576 HAEMOSTATIC FORCEPS SPENCERUELLS, KI | Artiberia | GEN | Class I | 1985-06-20 |
| K850018 | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYS ND:YAG | Laserscope | GEX | Class II | 1985-06-18 |
| K852241 | AXIOM ATRAUM TROCAR CATHETER | Axiom Medical, Inc. | GBS | Class I | 1985-06-14 |
| K852091 | ALBA DRY BURN PAD | Alba-Waldensian, Inc. | NAD | Class I | 1985-06-13 |
| K852141 | STERILE SURGICAL BLADES | Miltex Instrument Co. | GES | Class I | 1985-06-13 |
| K851452 | VALTRAC PURSESTING DEVICE | Davis & Geck, Inc. | HCF | Class I | 1985-06-12 |
| K852042 | BRIMFIELD CANNULATED BLADE HOLDER | Brimfield Scientific Instruments | GDZ | Class I | 1985-06-11 |
| K852011 | NYLAMID MESH PAD FULL & HALF | S. Jackson, Inc. | FTM | Class II | 1985-06-11 |
| K851974 | V. MUELLER VITAL SKIN STAPLER | American V. Mueller | GDT | Class I | 1985-06-11 |
| K851413 | EPILATOR 8500 | Lois Yee Cosmetics, Inc. | KCX | Class I | 1985-06-10 |
| K844874 | PENNINE LINK YANKAUERS | Pennine Medical , Ltd. | GEA | Class I | 1985-06-06 |
| K844876 | PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16, | Pennine Medical , Ltd. | GBX | Class I | 1985-06-05 |
| K851048 | CHEST CATHETERS/THORACIC CATHETERS | Medovations, Inc. | GBS | Class I | 1985-06-05 |
| K850535 | MITRATHANE DRESSING | Mitral Medical , Ltd. | NAD | Class I | 1985-06-05 |
| K851668 | PROSTHESIS OR SURGICAL PADS | Virginia Hall, Inc. | GBI | Class I | 1985-06-04 |
| K851084 | ECONOMY 400 CWS WITH PVC DRAINS | C.R. Bard, Inc. | GCY | Class I | 1985-06-04 |
| K851196 | INCISION DRAIN | Sil-Med Corp. | GCD | Class I | 1985-06-04 |
| K852184 | ELECTRO-CAUTERY KNIFE CLEANER 6000 1 | Dlp, Inc. | HAM | Class II | 1985-06-04 |
| K852150 | CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500 | Keeler Instruments, Inc. | HRM | Class I | 1985-06-03 |
| K852149 | PORTASUN MODEL 600/LI SUNLAMP | Portasun , Ltd. | FTC | Class II | 1985-05-31 |
| K851654 | OMNIMED CLAMP | Omni Intl., Inc. | HXD | Class I | 1985-05-31 |
| K850270 | CORNEAL LIGHT SHIELD | Mentor O & O, Inc. | HRM | Class I | 1985-05-31 |
| K851673 | RAKA OCH BOSDA PEANGER | General Electric Trading Co. | GEN | Class I | 1985-05-29 |
| K843206 | COOK COUNTY HOSPITAL DRESSING CHANGE SET | Geneva Laboratories, Inc. | KDD | Class I | 1985-05-24 |
| K851906 | SURGICAL EYE PACK | Xanmed Corp. | HMP | Class I | 1985-05-21 |
| K844061 | MICROTEK IRRIGATION SYSTEM | Microtek Medical, Inc. | GBX | Class I | 1985-05-21 |
| K851021 | MAYFIELD TABLE-ELECTRIC | Ohio Medical Instrument Co., Inc. | GDC | Class I | 1985-05-21 |
| K851880 | BRIMFIELD SCIEN. INSTRU. DISPOS. STERILE SURG. BLA | J-Pac, LLC | GFA | Class I | 1985-05-21 |
| K850011 | PROVAC WOUND HEALING/SUCTION SET | Medical Matrix, Inc. | GCY | Class I | 1985-05-21 |
| K844780 | EUROPLATE-CONDUCTIVE ADHESIVE ELECTROSURGICAL RETU | Poly- Med, Inc. | GEI | Class II | 1985-05-21 |
| K851086 | VICRYL (POLYGLACTIN 910/MERSILENE COMPOISITE MESH | ETHICON, Inc. | FTM | Class II | 1985-05-21 |
| K850943 | MODEL 775 BIPOLAR COAGULATOR | Birtcher Corp. | GEI | Class II | 1985-05-20 |
| K850749 | CONCEPT VIDEO IMAGING SYSTEM | Concept, Inc. | KQM | Class I | 1985-05-20 |
| K852053 | ORIGINAL ULTRAVIOLET SUNTANNING LAMP | Mottek Intl. Corp. | FTC | Class II | 1985-05-20 |
| K850668 | ELECTROSURGICAL UNIT 774 | Birtcher Corp. | GEI | Class II | 1985-05-20 |
| K851829 | SKYTRON ELITE 3100 SURGICAL TABLE | Skytron, Div. the Kmw Group, Inc. | GDC | Class I | 1985-05-17 |
| K851830 | SKYTRON ELITE 7000 MICRO-SURGERY TABLE | Skytron, Div. the Kmw Group, Inc. | GDC | Class I | 1985-05-17 |
| K851921 | Y CONNECTOR | Sil-Med Corp. | GCD | Class I | 1985-05-17 |
| K851527 | UTILIZATION OF ND:YAG LASER FOR TREATMENT RECTAL P | Endo Lase, Inc. | GEX | Class II | 1985-05-17 |
| K851823 | DISPOSABLE ISOLATION GOWN | American Threshold Industries, Inc. | FYC | Class II | 1985-05-17 |
| K851957 | CHIBA NEEDLE | Wilson-Cook Medical, Inc. | GAA | Class I | 1985-05-17 |
| K851953 | HAWKIN NEEDLE | Wilson-Cook Medical, Inc. | GAA | Class I | 1985-05-17 |
| K851859 | FACIAL/UPPER BODY UNIT | Tannhut | FTC | Class II | 1985-05-14 |
| K851858 | FOLD AWAY HUT | Tannhut | FTC | Class II | 1985-05-14 |
| K851675 | THE PERCUTANEOUS NEPHROSTOLITHOTOMY DRAPE | Lingeman Medical Products, Inc. | EYY | Class II | 1985-05-14 |
| K843915 | MINI-HALO CO2 LASER SYSTEM | CooperVision, Inc. | GEX | Class II | 1985-05-10 |
| K845029 | SURGICAL POWER MAGNET | Friedman Labs, Inc. | FTC | Class II | 1985-05-10 |
| K844643 | S.L.T. LASER DELIVERY HANDLES W/SURGICAL RODS | Surgical Laser Technologies, Inc. | GEX | Class II | 1985-05-10 |
| K844644 | SURGICAL LASER MICRO-TIPS | Surgical Laser Technologies, Inc. | GEX | Class II | 1985-05-10 |
| K851532 | SUNTANNING EQUIPMENT | Oakport Intl., Inc. | FTC | Class II | 1985-05-07 |
| K850282 | HYPAFIX POST OPERATIVE DRESSING | Smith & Nephew, Inc. | NAD | Class I | 1985-05-07 |
| K851487 | CODMAN DISPOSABLE BIPOLAR CARD | Codman & Shurtleff, Inc. | GEI | Class II | 1985-05-03 |
| K850912 | STERILE DISPOSABLE PN DRAPE SYSTEM | Brant-Wald Surgicals, Inc. | KKX | Class II | 1985-05-03 |
| K851443 | MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER | Micro-Aire Surgical Instruments, Inc. | HSZ | Class I | 1985-05-03 |
| K851475 | VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5 | Vygon Corp. | GBX | Class I | 1985-05-03 |
| K851612 | DERMA PREP | Mowbray Co., Inc. | KGT | Class I | 1985-05-03 |
| K851534 | PHILIPS UV-A SOLARIUM TYPE HP 3150 | Philips Int'L B.V. | FTC | Class II | 1985-05-01 |
| K851535 | PHILIPS UV-A SOLARIUM TYPE HP 3140 | Philips Int'L B.V. | FTC | Class II | 1985-05-01 |
| K851314 | ABCO DRAPES/TOWELS | Abco Dealers, Inc. | KKX | Class II | 1985-05-01 |
| K851536 | PHILIPS UV-A SOLARIUM TYPE HP 3141 | Philips Int'L B.V. | FTC | Class II | 1985-05-01 |
| K851533 | PHILIPS UV-A SDARIUM TYPE HP 3148(CFR 21 SUNLAMP | Philips Int'L B.V. | FTC | Class II | 1985-05-01 |
| K851554 | OVERSHOES (SURCHAUSSURES | Roseburg SA | FXP | Class I | 1985-04-30 |
| K851559 | TURQUOISE | Roseburg SA | FYA | Class II | 1985-04-30 |
| K851556 | OP-FACE MASK(MASQUE DE CHIRUGIE) | Roseburg SA | FXX | Class II | 1985-04-30 |
| K851558 | SURGICAL CAP CALOT | Roseburg SA | FYF | Class I | 1985-04-30 |
| K851482 | TOURNIQUET | Polymer Technology Corp. | GAX | Class I | 1985-04-29 |
| K851108 | VOLKMAN RETRACTOR 699-576 PCS. SHARP-4 PRONGS SS42 | The Huxley Instrument Corp. | GAD | Class I | 1985-04-25 |
| K851122 | PI-PNEUMO INTESTINAL STAPLING CARTRIDGE | Surgeons Choice, Inc. | GDW | Class II | 1985-04-25 |
| K851157 | SURGIMED - SURGICAL BLADES | Surgimed Corp. | GES | Class I | 1985-04-25 |
| K851170 | DISSECTING TWEEZER #283-72PCS. SS 410 | The Huxley Instrument Corp. | GEN | Class I | 1985-04-25 |
| K851106 | PRATT-SMITH T FORCEPS 1830-40 PCS. SS 420 OR 420F | The Huxley Instrument Corp. | GEN | Class I | 1985-04-25 |
| K851115 | FINOCCHIETO RIB RETRACTOR 1711-72 PCS. SS 303, 420 | The Huxley Instrument Corp. | GAD | Class I | 1985-04-25 |
| K851116 | JUDD-AILLIS TISSUE FORCEPS 1820-118 PCS. SS 410/42 | The Huxley Instrument Corp. | GEN | Class I | 1985-04-25 |
| K851114 | MAGILL FORCEPS 1711-46 PCS. SS 410 OR 420 | The Huxley Instrument Corp. | GEN | Class I | 1985-04-25 |
| K851255 | SUN BEDS | Tannhut | FTC | Class II | 1985-04-18 |
| K850273 | ETHICON - CHOLANGIOCLIP | ETHICON, Inc. | FZP | Class II | 1985-04-17 |
| K850904 | ALBA DRY BURN DRESSING | Alba Health Care | NAD | Class I | 1985-04-17 |
| K840113 | SILICONE SPLINTING MATERIAL | General Dental Products, Inc. | MDA | Class I | 1985-04-17 |
| K850076 | WOUND DRESSING MODEL ZB-6 | Thermedics, Inc. | NAD | Class I | 1985-04-15 |
| K850728 | MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE | Cooper Lasersonics, Inc. | LNK | Class II | 1985-04-08 |
| K850509 | ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM | Laser Media | LNK | Class II | 1985-04-08 |
| K844816 | MATRIX 101 NEGATIVE GALVANIC GENERATOR | Prn Medical | GEI | Class II | 1985-04-04 |
| K850779 | MODEL 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT | Cooper Lasersonics, Inc. | GEX | Class II | 1985-04-02 |
| K850168 | STILLE SCANDIA OPERATING TABLES RC 3000,1100 | Stille-Werner (Usa), Inc. | GDC | Class I | 1985-03-28 |
| K844858 | STORZ/URBAN SURGICAL MICROSCOPE SYSTEM | Storz Instrument Co. | EPT | Class I | 1985-03-25 |
| K850985 | FLEXUS 2 CO2 SURGICAL LASER SYSTEM | Intl. Solarium Manufacturer, Inc. | GEX | Class II | 1985-03-25 |
| K844130 | ACUFEX ARTHROSCOPIC SHAVER | Acufex Microsurgical, Inc. | HSZ | Class I | 1985-03-21 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.