Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 43
- Latest Decision
- 1977-11-28
Clearances · page 162 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K771680 | ARMOR-KOT SURGICAL INSTRUMENTS | Storz Instrument Co. | FSM | Class I | 1977-11-28 |
| K772160 | ELECTROSURGICAL GROUNDING PAD | Ndm Corp. | JOS | Class II | 1977-11-28 |
| K771412 | LIGACLIP MULTIPLE CLIP APPLIER | ETHICON, Inc. | GDO | Class I | 1977-11-28 |
| K771929 | PEDIATRICS GOWN | Convertors | FYB | Class II | 1977-11-16 |
| K771409 | DISP. SURGICAL FACE MASK | Precept, Inc. | FXX | Class II | 1977-10-27 |
| K770970 | HAIR TRANSPLANT PUNCH, MULTIPLH | Padgett Instruments, Inc. | GAH | Class I | 1977-10-27 |
| K771352 | ELECTROSURG. PATIENT GROUNDING PLATE | C.R. Bard, Inc. | GEI | Class II | 1977-10-25 |
| K771915 | MICRO OSCILLATING SAW | American Sterilizer Co. | HTZ | Class I | 1977-10-21 |
| K771178 | DISP. LOADING UNIT, AUTO, SUTURE | United States Surgical, A Division of Tyco Healthc | GDW | Class II | 1977-10-18 |
| K771806 | THOREK SCISSORS 7 1/4 & 10 | J. Sklar Mfg. Co., Inc. | FZT | Class I | 1977-10-04 |
| K771515 | SUTURE TISSUE APPROXIMATING FORCEP | United States Surgical, A Division of Tyco Healthc | GEN | Class I | 1977-09-30 |
| K771112 | AUTO SUTURE R CLIP | United States Surgical, A Division of Tyco Healthc | FZP | Class II | 1977-09-30 |
| K771007 | ELECTROSURGICAL POWER GENERATORS | Aspen Laboratories, Inc. | GEI | Class II | 1977-09-30 |
| K771640 | SUTURE CLIP REMOVER | United States Surgical, A Division of Tyco Healthc | GDO | Class I | 1977-09-30 |
| K771744 | OSTEOTOMES FOR CUTTING BONH | Depuy, Inc. | HWM | Class I | 1977-09-28 |
| K771751 | DISP. ELECTROSURGERY PENCIL | Edward Weck, Inc. | GEI | Class II | 1977-09-28 |
| K771745 | RASPS FOR SCRAPING BONE | Depuy, Inc. | HTR | Class I | 1977-09-28 |
| K771760 | EXTEMP | Pharmaco, Inc. | GAA | Class I | 1977-09-28 |
| K771752 | FINGER TIP CONTROL PENCIL | Edward Weck, Inc. | GEI | Class II | 1977-09-28 |
| K771759 | EXTEMP-V | Pharmaco, Inc. | GAA | Class I | 1977-09-28 |
| K771732 | THORNTON ANTERIOR CHAMBER IRRIGATOR | Concept, Inc. | GBQ | Class I | 1977-09-28 |
| K771746 | FORCEPS | Depuy, Inc. | GEN | Class I | 1977-09-26 |
| K771743 | SURG. SCISSORS FOR CUTTING TISSUE | Depuy, Inc. | FZT | Class I | 1977-09-26 |
| K771691 | ANGLED FORCEP APPLIER | Edward Weck, Inc. | GEN | Class I | 1977-09-22 |
| K771079 | CURITY IRRIGATION TRAY | Kendall Research Center | GBX | Class I | 1977-09-15 |
| K771575 | ELECTRONIC EIPLATOR MODEL NO. 101 | Electronic Depilatory, Inc. | KCX | Class I | 1977-09-06 |
| K771448 | STERILE SUTURE REMOVAL KIT | Premium Plastics, Inc. | KDD | Class I | 1977-09-06 |
| K771624 | COPE LUNG FORCEPS #305-218 | J. Jamner Surgical Instruments, Inc. | GEN | Class I | 1977-09-06 |
| K771332 | PATIENT GROUNDING CABLES | Edward Weck, Inc. | GEI | Class II | 1977-09-06 |
| K771329 | DISP. GROUND PAD PREGELLED | Edward Weck, Inc. | GEI | Class II | 1977-09-06 |
| K771330 | DISP. GROUND PLATE | Edward Weck, Inc. | GEI | Class II | 1977-09-06 |
| K771331 | CONDUCTIVE ELECTRODE GEL | Edward Weck, Inc. | GEI | Class II | 1977-09-06 |
| K771554 | SUTURE RETENTION CLAMP | Concept, Inc. | KGS | Class I | 1977-09-02 |
| K771395 | LAPAROTOMY SPONGES, STERILE | Medline Industries, Inc. | GDY | Class I | 1977-08-19 |
| K771440 | MACBICK CONDUCTIVE GEL - 000907 | C.R. Bard, Inc. | GEI | Class II | 1977-08-16 |
| K770924 | GREEN RADIOPAQUE IN SURG. SPONGES | Kendall Research Center | GDY | Class I | 1977-08-10 |
| K771408 | WROUGHT (FORGED) VITALLIUM | Howmedica Corp. | LZN | Class II | 1977-08-04 |
| K771186 | MICRO BI-POLAR FORCEPS #39-200 | Edward Weck, Inc. | HAM | Class II | 1977-07-15 |
| K771036 | SHAVE PREP TRAY | Parke-Davis Co. | KKX | Class II | 1977-07-14 |
| K771097 | FORCEP, DISP., A CLAMP | Dravon Medical, Inc. | HTD | Class I | 1977-07-14 |
| K771050 | HYPERALIMENTATION TRAY | American Hospital Supply Corp. | KKX | Class II | 1977-07-14 |
| K771136 | SURGICAL HEAD DRAPE, DISP. | Procter & Gamble Mfg. Co. | KKX | Class II | 1977-07-14 |
| K771071 | PORTO-VAC | Cpac, Inc. | JCX | Class II | 1977-07-14 |
| K771009 | ELECTRO-SURGICAL DEVICES | Deseret Pharmaceutical Co. | GEI | Class II | 1977-07-13 |
| K771187 | DERMAHOOK #382-805 | Edward Weck, Inc. | GDG | Class I | 1977-07-11 |
| K771190 | ABRAMSON TRACHEA HOOK & RETRACTOR | Edward Weck, Inc. | GDG | Class I | 1977-07-11 |
| K771192 | LOWMAN BONE FORCEP | Edward Weck, Inc. | HTD | Class I | 1977-07-11 |
| K771191 | HEISS RETRACTOR | Edward Weck, Inc. | GAD | Class I | 1977-07-11 |
| K771015 | VYGON RED-O-PACK | Coastal Bend Medical Products, Inc. | GCY | Class I | 1977-07-11 |
| K770802 | MARKERS, STAINLESS STEEL | Cardio-Surgical, Inc. | KPK | Class II | 1977-06-27 |
| K770862 | BLACK LAMPS,F72T12/BL/HO | Dermatron Corp. | FTC | Class II | 1977-06-27 |
| K770969 | CLEV-DENT COLHS ELECTROSURG, MOLEL TR-5 | Cavitron Corp. | GEI | Class II | 1977-06-24 |
| K770704 | GLOVES, SURGEONS, LATEX | Tillotson Rubber Co., Inc. | KGO | Class I | 1977-06-24 |
| K770799 | TRAY, IRRIGATION, STERILE, BASIC | Lukens Corp. | KKX | Class II | 1977-06-22 |
| K770796 | SKIN SCRUB PREP SET | Lukens Corp. | KKX | Class II | 1977-06-22 |
| K771045 | BLADES, SCALPEL | American Safety Razor Co. | GES | Class I | 1977-06-22 |
| K771006 | MODIFIED PODIATRY PRODUCTS | Dentronix, Inc. | HTZ | Class I | 1977-06-17 |
| K770861 | SURGICAL COLDLIGHT, AX8 | Affiliated Hospital Products, Inc. | FTD | Class II | 1977-06-17 |
| K771020 | SPINAL SURGERY FRAME | Orthopedic Systems, Inc. | JEB | Class I | 1977-06-17 |
| K771005 | NEW PODIATRY PRODUCTS | Dentronix, Inc. | HTZ | Class I | 1977-06-17 |
| K770410 | BANDAGE COMPRESS 2, 3, 4 | Johnson & Johnson Professionals, Inc. | NAB | Class I | 1977-06-09 |
| K770488 | ISOLATION GOWN | General Medical Co. | FYC | Class II | 1977-05-23 |
| K770812 | HANDLES, LIGHT, SURGICAL, STEOILE | Sybron Corp. | FQP | Class II | 1977-05-23 |
| K770647 | ELECTROSURGICAL GROUNDING CABLE | C.R. Bard, Inc. | GEI | Class II | 1977-05-23 |
| K770800 | HANDLES, BLADE, SURGICAL | Lukens Corp. | GES | Class I | 1977-05-06 |
| K770706 | CATHETER, IRRIGATION | Mallinckrodt Critical Care | GBX | Class I | 1977-05-06 |
| K770794 | SUTURE REMOVAL SET, STERILE | Lukens Corp. | KDC | Class I | 1977-05-06 |
| K770798 | BLADES, SURGICAL, STERILE | Lukens Corp. | GES | Class I | 1977-05-06 |
| K761179 | PSORALITE | Ultralite | FTC | Class II | 1977-05-03 |
| K770513 | MASK, SURGICAL, DISP | Acme Automatic Disposable | FXX | Class II | 1977-04-29 |
| K770759 | HOOK HOLLER | Depuy, Inc. | KIK | Class I | 1977-04-29 |
| K770646 | ELECTROSURGICAL PATIENT GROUNDING PAD | C.R. Bard, Inc. | GEI | Class II | 1977-04-28 |
| K770542 | SCISSORS, MAYO _TYLE, 14,16,18,20,22 CM. | Sea-Pac Trading Corp. | FZT | Class I | 1977-04-15 |
| K770540 | FORCEPS, MOSQUITO STYLE, 12.5 CM. | Sea-Pac Trading Corp. | GEN | Class I | 1977-04-15 |
| K770541 | SCISSORS, SURGICAL, 12.5,14,16 & 18 CM. | Sea-Pac Trading Corp. | FZT | Class I | 1977-04-15 |
| K770538 | FORCEPS, HAEMOSTATIC, 14 16,&18 CM. LONG | Sea-Pac Trading Corp. | GEN | Class I | 1977-04-15 |
| K770414 | PROBE RETRACTOR, PART #S-2L8-6 | Acme United Corp. | GAD | Class I | 1977-04-15 |
| K770543 | SCISSORS, SURGICAL, ANGULAR, 14 CM. | Sea-Pac Trading Corp. | FZT | Class I | 1977-04-15 |
| K770544 | SCISSORS, BANDAGE, 15,18,20CM., ANGULAR | Sea-Pac Trading Corp. | FZT | Class I | 1977-04-15 |
| K770539 | FORCEPS, HAEM, DEEP OPERATION, 20&22 CM. | Sea-Pac Trading Corp. | GEN | Class I | 1977-04-15 |
| K770651 | RETRACTORS & HOOKS, ABRAMSON | Edward Weck, Inc. | GAD | Class I | 1977-04-14 |
| K770568 | SURGICAL ILLUMINATOR (SIL) | Fiber Optics Engineering, Inc. | FTD | Class II | 1977-04-14 |
| K770567 | LIGHT, EXAMINATION, MEDICAL (MEL) | Fiber Optics Engineering, Inc. | FTD | Class II | 1977-04-14 |
| K770359 | IMPLANTING OF POLYACRYLIC FIBERS | Allan V. Marse | GBI | Class I | 1977-04-08 |
| K770621 | STOCKINETTE, SURGICAL | The Torrent Corp. | KKX | Class II | 1977-04-06 |
| K770329 | WOMB PREP KIT | American Hospital Supply Corp. | GEN | Class I | 1977-04-05 |
| K770560 | BARRIER O.B. PACK IV | Surgikos, Inc. | KKX | Class II | 1977-04-05 |
| K770217 | LANCE LTD. STERI. STITCH CUTTER BLADE | Aeroceuticals | GES | Class I | 1977-03-30 |
| K770442 | SUMP DRAIN, W/FILTER, ARGYLE EDLICH | Sherwood Medical Industries | GBX | Class I | 1977-03-30 |
| K760997 | UNDER BOTTOCKS DRAPE | C.R. Bard, Inc. | KKX | Class II | 1977-03-23 |
| K770418 | RETRACTOR, SKIN HOOK | Acme United Corp. | GAD | Class I | 1977-03-23 |
| K770463 | MASK, SURGICAL, FACE, DISPOSABLE | Precept, Inc. | FXX | Class II | 1977-03-23 |
| K770396 | DRAPES, MODESTY | Mark One Healthcare Products | KKX | Class II | 1977-03-23 |
| K770303 | NIPPER, NAIL, P610 ENGLISH | Dentronix, Inc. | FZT | Class I | 1977-03-09 |
| K770305 | CUTTER, P607 BONE | Dentronix, Inc. | FZT | Class I | 1977-03-09 |
| K770302 | CUTTER, P606 BONE | Dentronix, Inc. | FZT | Class I | 1977-03-09 |
| K770304 | CUTTER, P605 GENERAL PURPOSE | Dentronix, Inc. | FZT | Class I | 1977-03-09 |
| K770391 | COVER, ARMBOARD, DISPOSABLE | Precept, Inc. | BTX | Class I | 1977-03-07 |
| K770260 | CAP, CLARION NURSES OR (TECHNIC) | Sherwood Medical Industries | FYF | Class I | 1977-03-07 |
| K770301 | NIPPER, PSO4 TISSUE | Dentronix, Inc. | FZT | Class I | 1977-03-07 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.