Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 40
- Latest Decision
- 1979-10-22
Clearances · page 159 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K791541 | EMS ADAPTER MODEL 9160 | Concept, Inc. | GEI | Class II | 1979-10-22 |
| K791984 | SCISSOR'S #'S 2294,2262,2263 | Edward Weck, Inc. | FZT | Class I | 1979-10-17 |
| K791949 | DEXIDE DISPOSABLE SURGICAL SCRUB BRUSH | Dexide, Inc. | GEC | Class I | 1979-10-17 |
| K791845 | BAYONET HEIFETZ CLIP APPLIERS | Edward Weck, Inc. | GDO | Class I | 1979-10-17 |
| K791887 | CENTRAL VENOUS CATHETER DRESSING TRAY | Ascep, Inc. | FSM | Class I | 1979-10-17 |
| K791864 | INSTRUMENT PAD | Procter & Gamble Mfg. Co. | KKX | Class II | 1979-10-17 |
| K791926 | HAND TOWEL | Procter & Gamble Mfg. Co. | NAB | Class I | 1979-10-17 |
| K791951 | DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE | Dexide, Inc. | GEC | Class I | 1979-10-17 |
| K791889 | SUTURE REMOVAL TRAY, REORDER 7950&7951 | Ascep, Inc. | FSM | Class I | 1979-10-17 |
| K791952 | DEXIDE DISPOSABLE SURGICAL SCRUB BRUSH | Dexide, Inc. | GEC | Class I | 1979-10-17 |
| K791950 | DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE | Dexide, Inc. | GEC | Class I | 1979-10-17 |
| K791415 | MODEL 80-1765 ELECTROSURGICAL UNIT | Cameron-Miller, Inc. | GEI | Class II | 1979-10-11 |
| K791767 | BOVIE CSV HAND CONTROL ADAPTER | Sybron Corp. | GEI | Class II | 1979-10-11 |
| K791434 | SPONGE COUNTER BAGS | Medicare Industries, Inc. | KDC | Class I | 1979-10-09 |
| K791752 | LECTROVAC, VALLEYLAB MODELS | Valleylab, Inc. | GEI | Class II | 1979-10-04 |
| K791719 | BARRIER & FACE MASK WITH INNER FACING | Surgikos, Inc. | KKX | Class II | 1979-10-04 |
| K791859 | TECNOL STIRRUPS STRAP | Tecnol New Jersey Wound Care, Inc. | BWN | Class I | 1979-10-04 |
| K791987 | VASCULAR FORCEPS & CLAMPS | Edward Weck, Inc. | GEN | Class I | 1979-10-04 |
| K791759 | TEST PRESSURE GAUGE #6675-32 | Depuy, Inc. | KCY | Class I | 1979-10-04 |
| K791742 | BROOKS GALL BLADDER SCISSORS (SURG) | Edward Weck, Inc. | FZT | Class I | 1979-10-04 |
| K791741 | FLOOR LINE INSTRUMENTS | Edward Weck, Inc. | FZT | Class I | 1979-10-04 |
| K791703 | TEW BYPASS INSTRUMENTS & DISSECTING KIT | Edward Weck, Inc. | GDI | Class I | 1979-10-04 |
| K781445 | SPREADER | Orthopedic Equipment Co., Inc. | GAD | Class I | 1979-09-27 |
| K791743 | WECK RACK (STERILIZING ACCESSORY TRAY) | Edward Weck, Inc. | FSM | Class I | 1979-09-26 |
| K791806 | CONPHAR ADAPT-CONNECTS STERILE, NONSTE. | Conphar, Inc. | KGZ | Class I | 1979-09-21 |
| K791803 | CONPHAR CATHETER PLUG | Conphar, Inc. | KGZ | Class I | 1979-09-21 |
| K791802 | CONPHAR TUBE CLAMPS | Conphar, Inc. | GDJ | Class I | 1979-09-21 |
| K791800 | CONPHAR UMBILICAL CORD CLAMP | Conphar, Inc. | GDJ | Class I | 1979-09-21 |
| K791736 | MEROCEL INSTRUMENT WIPE | Xomed, Inc. | GEC | Class I | 1979-09-19 |
| K791665 | SCOTTS SURGICAL RETRACTOR AND ELASTIC | Lone Star Medical Products, Inc. | GAD | Class I | 1979-09-19 |
| K770428 | VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC. | Holco Instrument Corp. | FSM | Class I | 1979-09-12 |
| K791643 | BONE MARROW NEEDLE | Johannah Medical Services, Inc. | GDM | Class I | 1979-09-12 |
| K791639 | MODEL E2515 ELECTROSURGICAL ACCESSORY | Valleylab, Inc. | GEI | Class II | 1979-09-12 |
| K791372 | JELCO & KVO CATHETER PLACEMENT UNIT | Jelco Laboratories | JCY | Class I | 1979-09-12 |
| K791734 | SURGICAL INSTRUMENTS HEIFETZ DIGITATE | Edward Weck, Inc. | FZT | Class I | 1979-09-12 |
| K791638 | MODEL E2510 SURGISWITCH | Valleylab, Inc. | GEI | Class II | 1979-09-12 |
| K791349 | SYSTEC 280 INTEGRATED SUCTION SYSTEM | Stryker Corp. | BTA | Class II | 1979-09-07 |
| K791362 | ELECTROSURGICAL CUT AND COAGU ACCESSORY | Intermedics, Inc. | GEI | Class II | 1979-09-04 |
| K791116 | PSORALITE SERIES 30,000 | Paul B. Elder Co. | KGL | Class II | 1979-09-04 |
| K791438 | BARRIER* C-ARM DRAPE | Surgikos, Inc. | KKX | Class II | 1979-08-28 |
| K791440 | BARRIER* X-RAY CASSETTE DRAPE | Surgikos, Inc. | KKX | Class II | 1979-08-28 |
| K791486 | FABRIC 450* TOWEL DRAPE | Surgikos, Inc. | KKX | Class II | 1979-08-28 |
| K791439 | BARRIER* OVERHEAD TABLE DRAPE | Surgikos, Inc. | KKX | Class II | 1979-08-28 |
| K791500 | BARRIER *450* TAPE STRIP | Surgikos, Inc. | KKX | Class II | 1979-08-28 |
| K791369 | AIRSTRIP THEATRE WARD DRESSING | Acme United Corp. | NAD | Class I | 1979-08-28 |
| K791230 | ELECTROSURGICAL GENERATOR (TIM) | Concept, Inc. | GEI | Class II | 1979-08-16 |
| K791400 | GASTRIC LAVAGE KIT-DISPOSABLE | Acumed Instruments Corp. | GBQ | Class I | 1979-08-16 |
| K791224 | MALIBU LABS MODEL 800 FINGER TIP CONT | Malibu Laboratories | GEI | Class II | 1979-08-10 |
| K790855 | SURGICAL DRAPE CLIP #201 | C. Intl. | GDO | Class I | 1979-08-03 |
| K791056 | 3M CEMENT REMOVER | 3M Company | HSZ | Class I | 1979-07-30 |
| K791289 | GIZMO TOWEL CLAMP | Hemoy, Inc. | HXD | Class I | 1979-07-24 |
| K791210 | PORTABLE ASPIRATOR | Sam Say Assoc. | JCX | Class II | 1979-07-24 |
| K791286 | WECK MICROSURGICAL KNIFE | Vista Medical Products, Inc. | EMF | Class I | 1979-07-24 |
| K791239 | BRIOX MODEL 2000-A ASPIRATOR UNIT | Briox Technologies, Inc. | JCX | Class II | 1979-07-24 |
| K791241 | BRIOX MODEL 2000-CA COMPRESSOR UNIT | Briox Technologies, Inc. | JCX | Class II | 1979-07-24 |
| K791238 | BRIOX MODEL 2000-CQ QUIET COMPRESSOR | Briox Technologies, Inc. | JCX | Class II | 1979-07-24 |
| K791137 | SINGLE USE MONOPOLAR HAND CONTROL PENCIL | Davol, Inc. | GEI | Class II | 1979-07-24 |
| K791280 | OPERATION MICROSCOPE SOM 1 | Elmed, Inc. | FSO | Class I | 1979-07-24 |
| K791240 | BRIOX MODEL 2000-C COMPRESSOR UNIT | Briox Technologies, Inc. | JCX | Class II | 1979-07-24 |
| K780627 | SURG-O-PAK, GOWNS, SHEETS, AND TOWELS | Convertors | KKX | Class II | 1979-07-11 |
| K790597 | SENSOMAT SIDEARM ADAPTER | Biochem International, Inc. | KGZ | Class I | 1979-07-10 |
| K791122 | TISSURE RETRACTORS | Xomed, Inc. | GAD | Class I | 1979-07-10 |
| K791123 | EAR AND NOSE SPECULA | Xomed, Inc. | EPY | Class I | 1979-07-10 |
| K791166 | DEXIDE DISPOSABLE PREP SPONGE | Dexide, Inc. | NAB | Class I | 1979-07-10 |
| K791120 | MIDDLE EAR PICKS, HOOKS CURETTES, | Xomed, Inc. | GDG | Class I | 1979-07-10 |
| K790970 | SURGICAL FACE MASK | Carapace, Inc. | KKX | Class II | 1979-07-03 |
| K791157 | 360 HEMOCLIP APPLIERS | Edward Weck, Inc. | GDO | Class I | 1979-06-27 |
| K791125 | PLUG-LOK CEMENT RESTIRCTOR | Richard'S Medical Equip., Inc. | LZN | Class II | 1979-06-27 |
| K791062 | BOUNDARY SPECIALTY GOWN | Procter & Gamble Mfg. Co. | FYA | Class II | 1979-06-20 |
| K791070 | ACCU-SORB STERILE STOCKINETTES | Medline Industries, Inc. | KKX | Class II | 1979-06-20 |
| K791032 | CARDIAC CATHETERIZATION SHEETS/PACKS | Surgikos, Inc. | KKX | Class II | 1979-06-15 |
| K790444 | ELECATH MULTI-PURPOSE ARTERIAL SURGER | Electro-Catheter Corp. | GBA | Class I | 1979-06-11 |
| K790854 | FORCEPS #101 AND #102 | C. Intl. | GEN | Class I | 1979-06-05 |
| K790990 | REYNOLDS DOUBLE HEMOCLIP APPLIERS | Edward Weck, Inc. | GDO | Class I | 1979-06-05 |
| K790952 | CLAMP COVERS | Medi-Spec | GAD | Class I | 1979-06-05 |
| K790946 | GORDON IVS INTRAVENOUS STABILIZER | Whitman Medical Corp. | GBJ | Class I | 1979-06-05 |
| K790972 | KIMLON IMPERVIOUS STOCKINETTES | Kimberly-Clark Corp. | KKX | Class II | 1979-06-05 |
| K790872 | ENTERIC TUBE GUIDE | Biosearch Medical Products, Inc. | FZX | Class I | 1979-05-23 |
| K790684 | COLOR CODING OF SURGICAL INSTRUMENTS | Sara Dan, Inc. | FZT | Class I | 1979-05-18 |
| K790770 | SAFETY HOLSTER, SINGLE-USE | Aspen Laboratories, Inc. | GEI | Class II | 1979-05-18 |
| K790674 | THE SURGICAL ASSISTANT | Instrument Makar, Inc. | FWZ | Class I | 1979-05-14 |
| K790725 | BARRIER SURGICAL DRAPES W/ DRISITE* W/MICROCIDE* | Surgikos, Inc. | KKX | Class II | 1979-05-11 |
| K790642 | LEY ELECTRO-SURGICAL UNITS | Merced Medical, Inc. | GEI | Class II | 1979-05-08 |
| K790636 | KIMLON UNIVERSAL DRAPE | Kimberly-Clark Corp. | KKX | Class II | 1979-05-08 |
| K790431 | TREATED BARRIER INCISE DRAPE | Surgikos, Inc. | KKX | Class II | 1979-05-04 |
| K790802 | ESSAR TOURNIQUET FOR VENIPUNCTURE | Stewart Research, Inc. | GAX | Class I | 1979-05-01 |
| K790654 | CLOSED WOUND VACUUM DRAINAGE SYSTEM | 3M Company | GCY | Class I | 1979-04-26 |
| K790577 | HEMORRHOIDAL LIGATOR | J. Sklar Mfg. Co., Inc. | HCF | Class I | 1979-04-23 |
| K790645 | ENDOTOME | Berkeley Bio-Engineering | HSZ | Class I | 1979-04-23 |
| K790763 | MAXI-VAC TM | Med General | GCY | Class I | 1979-04-23 |
| K790660 | SURGICAL RULER | Richard-Allan Medical Ind., Inc. | FTY | Class I | 1979-04-12 |
| K790293 | CIMARRON 1000 OR 1000-2 | Cimarron Instruments, Inc. | GEI | Class II | 1979-04-12 |
| K790296 | ELECTRODE, MODEL E7504 PREP II | Valleylab, Inc. | GEI | Class II | 1979-04-12 |
| K790634 | IMPERVIOUS STERILE STOCKINETTE | Anago, Inc. | KKX | Class II | 1979-04-10 |
| K790491 | ITIMIZED INSTRUMENTS | E.M. Adams | FZT | Class I | 1979-04-04 |
| K790341 | DELTA-NET | Johnson & Johnson Professionals, Inc. | KKX | Class II | 1979-04-04 |
| K790472 | BURRON VENTED NEEDLE | National Patent Development Corp. | GAA | Class I | 1979-03-26 |
| K790389 | GAUZE & COTTON SPONGES | Medtech Intl., Inc. | GDY | Class I | 1979-03-26 |
| K790060 | NEEDLE II, BURRON FILTER | National Patent Development Corp. | GAA | Class I | 1979-03-21 |
| K782051 | DRAPES, DISPOSABLE SURGICAL | Marco Mfg. | KKX | Class II | 1979-03-21 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.