Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 44
- Latest Decision
- 1979-03-21
Clearances · page 160 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K790167 | SUNLAMP | Kneilsly Group Ent. | FTC | Class II | 1979-03-21 |
| K781772 | CATHETER, TRANSLUMINAL BALLOON | Medi-Tech, Inc. | GBA | Class I | 1979-03-06 |
| K790089 | TAPE MEASURE | Pfizer, Inc. | FTY | Class I | 1979-03-06 |
| K790367 | GRAB-IT | Concept, Inc. | GEI | Class II | 1979-03-02 |
| K790187 | BOVIE HAND CONTROL | Sybron Corp. | GEI | Class II | 1979-02-27 |
| K782119 | DEBUTRON | Martin Electric Co. | KCX | Class I | 1979-02-26 |
| K781799 | EKG, SWITCHING BLADE AND PENS | Bionex, Inc. | GEI | Class II | 1979-02-26 |
| K781949 | ELECTROSURGERY MODEL 771 | Birtcher Corp. | GEI | Class II | 1979-02-26 |
| K790195 | FOOT VALVE | American Safety | GET | Class I | 1979-02-26 |
| K790084 | SURGICAL RULER AND PEN | Devon Industries, Inc. | FZZ | Class I | 1979-02-26 |
| K790186 | PROTECTIVSTABILIZER | Jelco Laboratories | GBJ | Class I | 1979-02-26 |
| K790142 | NEEDLE, WITH FILTER | National Patent Development Corp. | GAA | Class I | 1979-02-26 |
| K790234 | DRAPE PACKS, SURGICAL GOWNS | Convertors | KKX | Class II | 1979-02-22 |
| K790306 | EDGE PROTECTOR, BARRIER | Surgikos, Inc. | KGW | Class II | 1979-02-22 |
| K790225 | LIMB SHEET WITH FABRIC 450 | Surgikos, Inc. | KKX | Class II | 1979-02-21 |
| K790224 | PADIATRY PACK & SHEET WITH FABRIC 450 | Surgikos, Inc. | KKX | Class II | 1979-02-16 |
| K782107 | LAP SPONGE | Carapace, Inc. | GDY | Class I | 1979-02-16 |
| K790061 | NEEDLE, BURRON FILTER | National Patent Development Corp. | GAA | Class I | 1979-02-16 |
| K790259 | STERILE DISPOSABLE KNIFE | Intermedics, Inc. | GDX | Class I | 1979-02-13 |
| K790063 | DRILL, CORDLESS SURGICAL | Richard'S Medical Equip., Inc. | KIJ | Class I | 1979-02-05 |
| K790079 | NEEDLE, BLOOD COLLECTING | Jelco Laboratories | GAA | Class I | 1979-02-01 |
| K782115 | ASTRA-VAC | Ab Astra | GCY | Class I | 1979-02-01 |
| K790053 | KELLEY-PLUS WITH MEASURETTE | John N. Haswell, M.D. | KKX | Class II | 1979-01-26 |
| K781664 | SILASTIC NEPHROSTOMY SYSTEM | Dow Corning Corp. Healthcare Industries Materials | GBO | Class I | 1979-01-22 |
| K782030 | LASER SYSTEM, SHARPLAN 791/HE, CO2 | Laser Industries , Ltd. | GEX | Class II | 1979-01-22 |
| K790050 | SPONGES, STANFORD STERILE LAP | Stanford Professional Products | GDY | Class I | 1979-01-17 |
| K782091 | STOCKINETTE, DISPOSABLESURGICAL | Anago, Inc. | KKX | Class II | 1979-01-10 |
| K782092 | ARMBOARD CVER, DISPOSABLE | Anago, Inc. | FSE | Class I | 1979-01-10 |
| K782172 | BRUSH/SPONGE, DISPOSABLE | Dexide, Inc. | GEC | Class I | 1979-01-10 |
| K781959 | SURGICAL GOWNS, SHEETS | Convertors | KKX | Class II | 1979-01-10 |
| K782173 | SURGERY BRUSH | Dexide, Inc. | GEC | Class I | 1979-01-10 |
| K781956 | CRYOSURGICAL DEVICE 2000 | Valleylab, Inc. | GEH | Class II | 1979-01-10 |
| K782104 | PASTE, PRO CARE PROPHYLAXIS | Young Dental Manufacturing Co. 1, LLC | FZE | Class II | 1979-01-03 |
| K781944 | STOCKINETTE | Kimberly-Clark Corp. | KKX | Class II | 1978-12-29 |
| K781979 | SURGAIRTOME TWO | American Sterilizer Co. | HSZ | Class I | 1978-12-20 |
| K782090 | CLAMP, DISPOSABLE | Concord Laboratories, Inc. | HXD | Class I | 1978-12-20 |
| K781810 | ELECTROSURGICAL UNIT 3001-3009 | Neomed Corp. | GEI | Class II | 1978-12-20 |
| K781682 | SURGICAL GOWNS & DRAPES | Kimberly-Clark Corp. | FYA | Class II | 1978-12-20 |
| K782028 | ROUND SILICONE DRAIN | Davol, Inc. | GCY | Class I | 1978-12-20 |
| K782006 | MEDGENERAL SINGLE-USE BULLDOG | Med General | GDJ | Class I | 1978-12-15 |
| K781665 | TUBE, LEATHERMAN/IMBRUCE | National Catheter Co. Div. Mallinckrodt | GBA | Class I | 1978-12-15 |
| K781846 | ADAPTER, CATHETER SHEATH | Arrow Intl., Inc. | KGZ | Class I | 1978-12-12 |
| K782026 | FLAT SILICONE DRAIN | Davol, Inc. | GCY | Class I | 1978-12-12 |
| K781887 | 9100 DAYSTAR AND 9110 ORBITER PACKAGE | Castle Co. | FSY | Class II | 1978-12-12 |
| K781694 | PEN, MARK-3 SKIN MARKING FOUNTAIN | Omega Mark-3 Pen Corp. | FZZ | Class I | 1978-12-04 |
| K781854 | PAD, B-D I.V. CATH. | Bd Becton Dickinson Vacutainer Systems Preanalytic | KGZ | Class I | 1978-12-04 |
| K780775 | MEDICAL PROTEIN HYDROLYSATE REVITAL | Robertson Resources, Inc. | KOZ | Class I | 1978-11-30 |
| K781770 | SKIN MARKING PEN | Abco Dealers, Inc. | FZZ | Class I | 1978-11-15 |
| K781818 | LAPARATOMY SPONGE | Meden Medical Sales Division | GDY | Class I | 1978-11-15 |
| K781797 | PREP TRAY, PREOPERATIVE SKIN | Pharmaseal Div., Baxter Healthcare Corp. | OJU | Class I | 1978-11-08 |
| K781698 | EXAMINER 10 | American Sterilizer Co. | HJE | Class II | 1978-11-03 |
| K781847 | LATEX, IN-HOUSE COMPOUNDED | Arbrook Mfg. Corp. | KGO | Class I | 1978-11-03 |
| K781539 | ISO-CARE KIT | Nice-Pak Products, Inc. | HMP | Class I | 1978-11-03 |
| K781716 | BLADE, 20 ANGLE/MICRO BLADE HOLDER | Edward Weck, Inc. | GES | Class I | 1978-10-24 |
| K781534 | SURG-O-PAK PREP PAD | Convertors | KKX | Class II | 1978-10-24 |
| K781453 | MODEL 770 ARGON LASER | Spectra-Physics, Inc. | GEX | Class II | 1978-10-24 |
| K781511 | LECTROSWITCH MODEL E2502B | Valleylab, Inc. | GEI | Class II | 1978-10-24 |
| K781510 | DISPOSABLE LECTROSWITCH, MODEL E2503 | Valleylab, Inc. | GEI | Class II | 1978-10-24 |
| K781581 | SURGICAL LIGHT 22 SERIES | American Sterilizer Co. | FQP | Class II | 1978-10-17 |
| K780720 | IDENTI-LOOPS | Berkeley Bio-Medical, Inc. | GAD | Class I | 1978-10-17 |
| K780721 | IDENTI-CLAMPS | Berkeley Bio-Medical, Inc. | GDJ | Class I | 1978-10-17 |
| K781147 | EPILATOR, EASE-MULTI-MODE | Greenleaf-Carter Enterprises, Inc. | KCW | Class I | 1978-10-10 |
| K780989 | DEVIN-NESTOR SQUARE KNIFE | Nestor Engineering Associates, Inc. | EMF | Class I | 1978-10-03 |
| K780991 | PARALLEL BLADE MARKER | Nestor Engineering Associates, Inc. | EMF | Class I | 1978-10-03 |
| K780988 | DEVIN-NESTOR PNEUMATIC TOURNIQUET | Nestor Engineering Associates, Inc. | KCY | Class I | 1978-10-03 |
| K781574 | PLASTI-PORE SEPTAL BUTTON | Richard'S Medical Equip., Inc. | FZE | Class II | 1978-09-27 |
| K781447 | THREADED ROD CLAMP | Orthopedic Equipment Co., Inc. | GEN | Class I | 1978-09-27 |
| K781449 | HARRINGTON SPINAL ELEVATOR | Orthopedic Equipment Co., Inc. | GEG | Class I | 1978-09-27 |
| K781448 | HARRINGTON HOOK CLAMP | Orthopedic Equipment Co., Inc. | GEN | Class I | 1978-09-27 |
| K781446 | C RING CLINCHER | Orthopedic Equipment Co., Inc. | GEN | Class I | 1978-09-27 |
| K781450 | DRIVERS | Orthopedic Equipment Co., Inc. | GFC | Class I | 1978-09-27 |
| K781400 | HEMOVAC TUBING MATERIAL CHANGE | Snyder Laboratories, Inc. | GCY | Class I | 1978-09-20 |
| K781371 | BONE MARROW ASPIRATION KIT | Ferris Mfg. Corp. | GAA | Class I | 1978-09-20 |
| K781264 | PAB CONVENIENCE TRAY | Waters Assoc., Inc. | GAA | Class I | 1978-09-20 |
| K781526 | SILASTIC U-TUBE KIT | Dow Corning Corp. Healthcare Industries Materials | GBO | Class I | 1978-09-20 |
| K781429 | HAND-TROL CONNECTOR EXTENDER | Aspen Laboratories, Inc. | GEI | Class II | 1978-08-31 |
| K781172 | U-DRAPE, BOUNDARY | Procter & Gamble Mfg. Co. | KKX | Class II | 1978-08-31 |
| K781148 | ELECTROSURGICAL PENCIL SYSTEM | Medical Plastics, Inc. | GEI | Class II | 1978-08-31 |
| K780848 | PORTABLE CLOSED WOUND SUCTION EVACUATOR | Biomet, Inc. | GCY | Class I | 1978-08-23 |
| K780896 | NEEDLES, DESIGN CHANGE, IV CATHETERS | Jelco Laboratories | GCB | Class I | 1978-08-23 |
| K780548 | DISPOSA-LOOPS | Medi-Spec | KKX | Class II | 1978-08-21 |
| K780865 | MAGNETIC DRAPE - INSTRUMENT HOLDER | Devon Industries, Inc. | KKX | Class II | 1978-08-21 |
| K781047 | DRAPE, SURGICAL-SPARTAN LIMB SHEET | Spartan Healthcare Products Co. | KKX | Class II | 1978-08-18 |
| K781046 | IMPERVIOUS STOCKINET | Spartan Healthcare Products Co. | KKX | Class II | 1978-08-18 |
| K781233 | IV ARMBOARDS | Fibre Formations, Inc. | BTX | Class I | 1978-08-14 |
| K780840 | BARRIER LAPAROTOMY SHEET 450 | Surgikos, Inc. | KKX | Class II | 1978-08-14 |
| K780784 | ASPIRATION NEEDLE | Ferris Mfg. Corp. | KKX | Class II | 1978-08-14 |
| K780844 | BARRIER OBSTETRICAL PACK FABRIC 450 | Surgikos, Inc. | KKX | Class II | 1978-08-14 |
| K780853 | OP-SITE ADHESIVE DRAPES | Acme United Corp. | KKX | Class II | 1978-08-14 |
| K780841 | BARRIER MEDIUM SHEET 450 | Surgikos, Inc. | KKX | Class II | 1978-08-14 |
| K781019 | SURG. GOWN & DRAPE, LOW LINT TREATMENT | Kimberly-Clark Corp. | KKY | Class II | 1978-08-14 |
| K780839 | BARRIER PEDIATRIC/INCISE DRAPE 450 | Surgikos, Inc. | KKX | Class II | 1978-08-14 |
| K780868 | CHEST ROLLS | Devon Industries, Inc. | FSE | Class I | 1978-08-14 |
| K781099 | SURGICAL GOWNS AND DRAPES | Convertors | FYA | Class II | 1978-08-14 |
| K780843 | BARRIER ABDOMINAL PACK FABRIC 450 | Surgikos, Inc. | KKX | Class II | 1978-08-14 |
| K780867 | PAD HOLDER KIT | Devon Industries, Inc. | FSE | Class I | 1978-08-14 |
| K780842 | BARRIER BASIC PACK FABRIC 450 | Surgikos, Inc. | KKX | Class II | 1978-08-14 |
| K780856 | BARRIER GYNECOLOGY PACK FABRIC 450 | Surgikos, Inc. | KKX | Class II | 1978-08-14 |
| K780866 | CHEST ROLLS HOLDER | Devon Industries, Inc. | FSE | Class I | 1978-08-14 |
| K780993 | ULTRASOUND IMAGING SYSTEM | Boehringer Mannheim Corp. | GAD | Class I | 1978-08-10 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.