Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 41
- Latest Decision
- 1985-09-16
Clearances · page 143 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K853601 | MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP | Bowen & Company, Inc. | GAC | Class I | 1985-09-16 |
| K853248 | CHALLENGER SUNRISE | Challenge Products, Inc. | FTC | Class II | 1985-09-13 |
| K853394 | 600/L 5X6' UVA 85W LAMPS, 5X5 UVA 65W LAMPS 500/L | Interlab(Electromechanical) | FTC | Class II | 1985-09-13 |
| K853538 | CANNULA CLAMP | Cp Medical | HXD | Class I | 1985-09-12 |
| K853480 | SKYTRON ELITE 6000 & 6001 SURGICAL TABLES | Skytron, Div. the Kmw Group, Inc. | GDC | Class I | 1985-09-12 |
| K853537 | VELCRO TOURNIQUET | Cp Medical | GAX | Class I | 1985-09-12 |
| K853312 | ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES | Argon Medical Corp. | DWO | Class I | 1985-09-12 |
| K853535 | TRAUMA TABLE | Xre Corp. | GDC | Class I | 1985-09-11 |
| K851304 | NON/GEL ADHESIVE DISPERSIVE ELECTRODE 3427,33-4270 | Richards Medical Co., Inc. | GEI | Class II | 1985-09-06 |
| K851305 | NON/GEL FULLY ADHESIVE DISPERSIVE ELECTRODE 3428, | Richards Medical Co., Inc. | GEI | Class II | 1985-09-06 |
| K853347 | MAI STERILE UTILITY DRAPE | Medical Assoc. Intl., Inc. | KKX | Class II | 1985-09-05 |
| K853131 | THORO/CATH STRAIGHT THORACIC RIGHT ANGLE | J. H. Emerson Co. | GBS | Class I | 1985-09-05 |
| K853479 | SKYTRON ELITE 300 SURGERY TABLE | Skytron, Div. the Kmw Group, Inc. | FWW | Class I | 1985-09-05 |
| K852355 | SINGLE USE ARTHROSCOPY ELECTRODE | Aspen Laboratories, Inc. | GEI | Class II | 1985-09-03 |
| K852190 | MODEL 451 CO2 SURGICAL LASER | Coherent Medical Group | GEX | Class II | 1985-08-23 |
| K853334 | NON-ADHERA ADHESIVE PAD 3X4 | American White Cross, Inc. | NAD | Class I | 1985-08-21 |
| K852897 | LEE BONE MARROW BIOPSY/ASPIRATION TRAY | Southland Instruments, Inc. | GAA | Class I | 1985-08-21 |
| K852122 | MEDILASER MIC MODEL MEL-445C, 15W | Mochida Pharmaceutical Co., Ltd. | GEX | Class II | 1985-08-20 |
| K853295 | EMODREN EXCHANGEABLE PLASTIC BELLOWS | Parexel Intl. Corp. | GCY | Class I | 1985-08-20 |
| K852121 | MEDILASER MIC MODEL MEL 440-C;30W | Mochida Pharmaceutical Co., Ltd. | GEX | Class II | 1985-08-20 |
| K851318 | GUIBOR MICROELECTROLYSIS UNIT 18 | Galvanic Medical Instruments, Inc. | KCW | Class I | 1985-08-20 |
| K852575 | WALDMANN F85/100W PUVA | Sylvania Lighting Products | KGL | Class II | 1985-08-16 |
| K850804 | CO 2 SURGICAL LASER SYSTEM NA-30 | Xanar, Inc. | GEX | Class II | 1985-08-15 |
| K850805 | CO 2 SURGICAL LASER SYSTEM MODEL NA-40 | Xanar, Inc. | GEX | Class II | 1985-08-15 |
| K850818 | CO 2 SURGICAL LASER SYSTEM NA-120 | Xanar, Inc. | GEX | Class II | 1985-08-15 |
| K852646 | THERMATIC SUCTION PUMP | H.C.H. Products, Inc. | BTA | Class II | 1985-08-15 |
| K851000 | COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY | Cooper Lasersonics, Inc. | GEX | Class II | 1985-08-14 |
| K853177 | ECUMOL ULTRAVIOLET SUNTANNNING BEDS | Mottek Intl. Corp. | FTC | Class II | 1985-08-13 |
| K852683 | ELECTROSURGICAL LATERAL RELEASE PROBE MOD ALR-100 | American Bentley | GEI | Class II | 1985-08-12 |
| K852449 | HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER | Howmedica Corp. | LZN | Class II | 1985-08-12 |
| K853168 | MALIS BIPOLAR PEN | Valley Forge Scientific Corp. | GEI | Class II | 1985-08-12 |
| K853046 | TAN MODEL I | Philip Munsterman Tan, Inc. | FTC | Class II | 1985-08-07 |
| K853153 | MEDUS GMBH | Corkes Medical Co. | GEN | Class I | 1985-08-07 |
| K850628 | SHARPLAN 1040 CO/2 SURGICAL LASER | Laser Industries , Ltd. | GEX | Class II | 1985-08-07 |
| K850633 | SHARPLAN MODEL 1060 CO/2 SURGICAL LASER | Laser Industries , Ltd. | GEX | Class II | 1985-08-07 |
| K853103 | MCKNIFE | Medical Dimensions | GDX | Class I | 1985-08-06 |
| K853114 | ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR | Australian Biomedical Corporation , Ltd. | GAD | Class I | 1985-08-06 |
| K852415 | TITANIUM PROBES | L.A.S.E.R., Inc. | GAD | Class I | 1985-08-02 |
| K852586 | CROMIC SURGICAL MICROSCOPE MODEL MC-1 | Seltrex, Corp. | HRM | Class I | 1985-07-30 |
| K852945 | HUCK TOWEL | South Mountain Medical | KKX | Class II | 1985-07-29 |
| K853015 | SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420 | The Huxley Instrument Corp. | GEN | Class I | 1985-07-29 |
| K852957 | SAHARA SUNBED | Sahara Sun Beds., Inc. | FTC | Class II | 1985-07-29 |
| K852798 | FIBERLASE 100 MEDICAL LASER SYSTEM | Laser Media | LNK | Class II | 1985-07-29 |
| K852817 | STERILE, DISPOSABLE NEEDLE | Fabersanitas, S.A. | GAA | Class I | 1985-07-26 |
| K852870 | BARRIER SURGICAL GOWN | Surgikos, Inc. | FYA | Class II | 1985-07-23 |
| K852211 | OPSITE WOUND DRESSING | Smith & Nephew, Inc. | NAD | Class I | 1985-07-23 |
| K852715 | MAGILL FORCEPS, ADULT, 10 + SS 410 OR 420 | The Huxley Instrument Corp. | HTD | Class I | 1985-07-15 |
| K852728 | KELLY HEMOSTATIC FORCEPS, STRAIGHT 5-1/2+SS | The Huxley Instrument Corp. | HTD | Class I | 1985-07-15 |
| K852711 | SCALPEL HANDLE #3 SS 410 OR 420 | The Huxley Instrument Corp. | GDZ | Class I | 1985-07-15 |
| K852730 | CRILE FORCEPS, STRIAGHT, 6-1/4+SS 410 OR 420 | The Huxley Instrument Corp. | GEN | Class I | 1985-07-15 |
| K852727 | ROCHESTER - PEAN FORCEPS, STRAIGHT, 6-1/4+SS | The Huxley Instrument Corp. | HTD | Class I | 1985-07-15 |
| K852713 | RUSSIAN TISSUE FORCEPS, 6 + SS 410 OR 420 | The Huxley Instrument Corp. | HTD | Class I | 1985-07-15 |
| K852723 | FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 | The Huxley Instrument Corp. | HTD | Class I | 1985-07-15 |
| K852720 | THUMB DRESSING FORCEPS, 5+SS 410 OR 420 | The Huxley Instrument Corp. | HTD | Class I | 1985-07-15 |
| K852722 | STERILIZING FORCEPS, 3-PRONGE, 11+SS 410 OR 420 | The Huxley Instrument Corp. | HTD | Class I | 1985-07-15 |
| K852729 | AALSTEAD MOSQ. FORCEPS, STRAIGHT, 5+SS 410 OR 420 | The Huxley Instrument Corp. | HTD | Class I | 1985-07-15 |
| K852718 | ADSON TISSUE FORCEPS, 1X2 TEETH 4-3/4+SS | The Huxley Instrument Corp. | HTD | Class I | 1985-07-15 |
| K852717 | IRIS FORCEPS, DELICATE, 1X2 TEETH, STRAIGHT, 4XSS | The Huxley Instrument Corp. | GEN | Class I | 1985-07-15 |
| K852724 | BACKHAUS TOWEL CLAMP, 5-1/2 + SS 410 OR 420 | The Huxley Instrument Corp. | GDJ | Class I | 1985-07-15 |
| K852735 | SCALPEL HANDLE #7 SS 410 OR 420 | The Huxley Instrument Corp. | GDZ | Class I | 1985-07-15 |
| K852661 | APOLLO STERILE BLADES | Orthofab, Inc. | GES | Class I | 1985-07-11 |
| K852576 | WALDMANN F85/100W UV6 | Sylvania Lighting Products | FTC | Class II | 1985-07-11 |
| K852684 | WALDMANN F85/100W UV21 | Sylvania Lighting Products | FTC | Class II | 1985-07-11 |
| K852541 | STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS | Storz Instrument Co. | GFI | Class I | 1985-07-11 |
| K851040 | CONCEPT DEFRERE ELECTRODE | Concept, Inc. | GEI | Class II | 1985-07-11 |
| K852402 | NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER | North American Instrument Corp. | FZX | Class I | 1985-07-11 |
| K852567 | 3M FUKUDA TYPE RING RETRACTOR | 3M Company | GAD | Class I | 1985-07-09 |
| K852280 | DRAPES(SURGICAL, GENERAL & PLASTIC SURGERY) | Outpatient Products Co. | KKX | Class II | 1985-07-09 |
| K851382 | CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING | Chesebrough-Pond'S U.S.A. Co. | NAD | Class I | 1985-07-05 |
| K851383 | BLISTERFILM TRANSPARENT DRESSING | Chesebrough-Pond'S U.S.A. Co. | NAD | Class I | 1985-07-05 |
| K851408 | SUN FLOWER SOLETTE MINETTE NOVA SUPER 28X, PRO SER | Applied Science, Inc. | FTC | Class II | 1985-07-05 |
| K852579 | THE SUNTANNING CO. TANNING BED | The Suntanning Company, Inc. | FTC | Class II | 1985-07-03 |
| K852332 | TABLE ACCESSORIES, OPERATING ROOM | Scholten Surgical Instruments, Inc. | BWN | Class I | 1985-07-02 |
| K851251 | AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200 | Edward Weck, Inc. | FZP | Class II | 1985-07-02 |
| K852120 | FORCEPS, BIOPSY(NON RIGID) | Scholten Surgical Instruments, Inc. | GEN | Class I | 1985-07-02 |
| K852558 | SPLINTS(ALL TYPE) | The Huxley Instrument Corp. | FYH | Class I | 1985-07-02 |
| K851728 | 2250/1 TO 2285/2 VARIOUS COTTON TWEEZERS | Artiberia | GEN | Class I | 1985-07-01 |
| K851938 | OMNIMED SURGICAL GOWN | Omni Intl., Inc. | FYA | Class II | 1985-06-28 |
| K852530 | WEITIANER MASTOID 3 VS 4 BLUNT & SHARP PRONGS | The Huxley Instrument Corp. | GAD | Class I | 1985-06-28 |
| K852531 | NON-PERFORATING TOWEL FORCEPS-5-1/4 IN SS 410 | The Huxley Instrument Corp. | GEN | Class I | 1985-06-28 |
| K850789 | FLUTED SUCTION MENISCAL CUTTER | T. Korossurgical Instruments Corp. | KIJ | Class I | 1985-06-28 |
| K850634 | SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS | Surgidyne, Inc. | GCY | Class I | 1985-06-28 |
| K852426 | MANAN TROCAR STYLE BIOPSY NEEDLE | Manan Manufacturing Co., Inc. | GAA | Class I | 1985-06-27 |
| K852428 | MANAN EPIDURAL NEEDLE | Manan Manufacturing Co., Inc. | GCB | Class I | 1985-06-27 |
| K844809 | CONTINUOUS VENTILATOR | Hamilton Medical, Inc. | GBX | Class I | 1985-06-27 |
| K852243 | KETTLER ULTRAVIOLET SUNTANNING BENCHES & LIFTS | Mottek Intl. Corp. | FTC | Class II | 1985-06-27 |
| K852252 | 870 SURGICAL SYS CONTROL PULSE MODIFICATION | Cooper Lasersonics, Inc. | GEX | Class II | 1985-06-27 |
| K852277 | CATAPRESS TOURNIGUET | Boehringer Ingelheim Pharmaceuticals, Inc. | GAX | Class I | 1985-06-27 |
| K852427 | MANAN SPINAL NEEDLE | Manan Manufacturing Co., Inc. | GAA | Class I | 1985-06-27 |
| K852330 | RETRACTOR, SURGICAL | Scholten Surgical Instruments, Inc. | GAD | Class I | 1985-06-27 |
| K852348 | PHILIPS SOLARIUM HP 3134 | Philips Int'L B.V. | FTC | Class II | 1985-06-27 |
| K850635 | ANSELL NO POWDER SURGEON'S GLOVES | Ansell, Inc. | KGO | Class I | 1985-06-26 |
| K852143 | HALL IRRIGATION SYSTEM | Hall Surgical, Division of Zimmer, Inc. | GBX | Class I | 1985-06-26 |
| K852290 | PRIVATAN HOME TANNING CENTER | Privatan, Inc. | FTC | Class II | 1985-06-21 |
| K851752 | 9-190,9-200,9-210,9-220 AMPUTATION KNIVES, VARIOUS | Artiberia | GDN | Class I | 1985-06-20 |
| K851784 | 27-210 PLASTER KNIFE (REINER) | Artiberia | EMF | Class I | 1985-06-20 |
| K851802 | 69-140 TO 69-160 VARIOUS NAIL CUTTERS | Artiberia | LRW | Class I | 1985-06-20 |
| K851782 | 25-450 TO 25-540 VARIOUS SUTURE FORCEPS | Artiberia | GDL | Class I | 1985-06-20 |
| K851769 | VARIOUS DRESSING/TISSUE FORCEPS(ENGLISH, THUMB, TR | Artiberia | HTD | Class I | 1985-06-20 |
| K851774 | 17-900 TO 17-980 VARIOUS TOWEL CLAMPS | Artiberia | GDJ | Class I | 1985-06-20 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.