Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 38
- Latest Decision
- 1986-07-30
Clearances · page 140 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K862696 | TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP | Downs Surgical , Ltd. | HBT | Class I | 1986-07-30 |
| K862664 | JEDMED CCD CAMERA SYSTEM | Jedmed Instrument Co. | FWD | Class I | 1986-07-30 |
| K861456 | SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR | Pantheon Products, Inc. | HMP | Class I | 1986-07-25 |
| K861173 | OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO | Trimedyne, Inc. | LNK | Class II | 1986-07-25 |
| K862577 | LINEN (HUCK) TOWEL | Dimed, Intl. | KKX | Class II | 1986-07-23 |
| K862597 | VARIOUS SURGICAL INSTRUMENTS | Konig W.G., Ltd. | GAD | Class I | 1986-07-23 |
| K861742 | ELECTRO-SURGICAL PENCILS | Stryker Corp. | GEI | Class II | 1986-07-23 |
| K862481 | CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE | CIVCO Medical Instruments Co., Inc. | GDM | Class I | 1986-07-23 |
| K862404 | REFLEX(TM) CLIP APPLIER | Richard-Allan Medical Ind., Inc. | FZP | Class II | 1986-07-23 |
| K862629 | SURGICAL LASER ACCESSORIES (SLA) CASE | Simpson/Basye, Inc. | FSM | Class I | 1986-07-17 |
| K862474 | HALL STERNUM SAW | Hall Surgical, Division of Zimmer, Inc. | DWH | Class I | 1986-07-17 |
| K862438 | SURGICAL DRAPES AND DRAPE ACCESSORIES | Avery Intl. | KKX | Class II | 1986-07-16 |
| K862576 | PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN) | Professional Services For Surgeons, Ltd. | FTY | Class I | 1986-07-15 |
| K861142 | MASTER KIT B | Pro-Lab, Inc. | LRP | Class I | 1986-07-10 |
| K862341 | TANNING SOFA | Hardwood Design Shop | FTC | Class II | 1986-07-09 |
| K862372 | ULTRATAN TANNING SYSTEM | Health Systems Intl., Inc. | FTC | Class II | 1986-07-09 |
| K861614 | GHI WET PENCIL | Surgical Products Corp. | GEI | Class II | 1986-07-08 |
| K860974 | MODEL 545-45 LASER FOR DERMA., POD., SURGICAL | Britt Corp., Inc. | GEX | Class II | 1986-07-07 |
| K860085 | LYOFOAM WOUND DRESSINGS | Acme United Corp. | NAD | Class I | 1986-06-27 |
| K861972 | DERMISTRIP | Kells Medical, Inc. | NAD | Class I | 1986-06-27 |
| K861963 | ULTRALITE HF1236 HAND AND FOOT SYSTEM | Ultralite | FTC | Class II | 1986-06-25 |
| K854473 | PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGIC | Minnesota Laser Corp. | GEX | Class II | 1986-06-20 |
| K861903 | #6000 ND:YAG LASER SYSTEM UROLOGY/GASTROINTESTINAL | Cooper Lasersonics, Inc. | LNK | Class II | 1986-06-20 |
| K862263 | PERSUNAL TAN, MODEL NO. HU-0208L | Sunthetic Engineering, Inc. | FTC | Class II | 1986-06-20 |
| K854468 | PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC | Minnesota Laser Corp. | GEX | Class II | 1986-06-20 |
| K862172 | QUALI-MED'S OPERATING ROOM DRAPES | Quali-Med, Inc. | KKX | Class II | 1986-06-19 |
| K861372 | ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORY | Snowden-Pencer | GEI | Class II | 1986-06-19 |
| K861495 | ELECTROSURGICAL BLADE ELECTRODE (SOLID TYPE) | National Wire & Stamping, Inc. | GEI | Class II | 1986-06-19 |
| K861594 | ELECTROSURGICAL NEEDLE ELECTRODE (SOLID TYPE) | National Wire & Stamping, Inc. | GEI | Class II | 1986-06-19 |
| K861595 | BALL ELECTRODES | National Wire & Stamping, Inc. | GEI | Class II | 1986-06-19 |
| K853900 | ENDO-LASE CD40 FOR NEUROSURGERY | Endo Lase, Inc. | GEX | Class II | 1986-06-18 |
| K862142 | SUN-DREAMER SUNTANNING BED | Sun-Dream Tanning , Ltd. | FTC | Class II | 1986-06-17 |
| K861047 | MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINAL | Sharplan Industries, Inc. | LNK | Class II | 1986-06-17 |
| K862097 | FACE TANNER | Tan America Mfg. | FTC | Class II | 1986-06-17 |
| K862154 | VENESECTION EQUIPMENT STORAGE TRAY | Rmp Co. | FSM | Class I | 1986-06-16 |
| K861922 | TITANIUM HEMOSTATIC CLIPS | Pilling Co. | FZP | Class II | 1986-06-13 |
| K862145 | JEDMED MINI-MOS VIDEO CAMERA | Jedmed Instrument Co. | FWD | Class I | 1986-06-13 |
| K862062 | NONWOVEN SURGICAL DRAPE PACK | East Texas Lighthouse For the Blind | KKX | Class II | 1986-06-10 |
| K861306 | SUCTION SYSTEM | Axiom Medical, Inc. | GEA | Class I | 1986-06-09 |
| K861989 | MODIFICATION OF SUNTANA SUN SYSTEM BED | Hawaiian Tan Spa | FTC | Class II | 1986-06-09 |
| K862034 | JEDMED CCD-02 VIDEO CAMERA SYSTEM | Jedmed Instrument Co. | FWD | Class I | 1986-06-09 |
| K862010 | CHICK SURGICAL LIGHT | Professional Medical Products, Inc. | FTA | Class II | 1986-06-09 |
| K861953 | PARALLEL ACTION PLIERS | Med-Tool, Inc. | HTC | Class I | 1986-06-06 |
| K861471 | V. MUELLER VITAL CLIP-HEMOSTATIC CLIP | American V. Mueller | FZP | Class II | 1986-06-06 |
| K861947 | SURGICAL KNIFE | Sharpoint, Inc. | EMF | Class I | 1986-06-06 |
| K861969 | STERILE TOWEL W/ANTIMICROBIAL AGENT | Deroyal Industries, Inc. | KKX | Class II | 1986-06-04 |
| K862016 | PACH-PEN SURGICAL DRAPE | Oculab, Inc. | KKX | Class II | 1986-06-04 |
| K861877 | BYRON WORD BARTHOLIAN GLAND CATHETER | Byron Medical | GBA | Class I | 1986-05-30 |
| K861530 | SURGICAL PACKS, KITS AND TRAYS | Medical Concepts Development, Inc. | FSM | Class I | 1986-05-30 |
| K861441 | NEUTRALON SURGICAL GLOVES | Surgikos, Inc. | KGO | Class I | 1986-05-30 |
| K861876 | CRANIO BLADES AND WIRE PASS DRILL | New England Surgical Instrument Corp. | GFA | Class I | 1986-05-30 |
| K861807 | MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP) | Medcomp Technologies, Inc. | HRQ | Class I | 1986-05-23 |
| K861749 | 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE | Keeler Instruments, Inc. | FSP | Class I | 1986-05-23 |
| K861805 | MEDCARE FORCEPS (THUMB, TISSUE) | Medcomp Technologies, Inc. | GEN | Class I | 1986-05-23 |
| K861531 | DISPOSABLE SURGICAL DRAPES AND ACCESSORIES | Medical Concepts Development, Inc. | KKX | Class II | 1986-05-23 |
| K861806 | MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT) | Medcomp Technologies, Inc. | KDA | Class II | 1986-05-23 |
| K861772 | LASER SKIN MARKER AND MASK WHITE LOTION | Pacific Poly Crafts | FZZ | Class I | 1986-05-21 |
| K861112 | MODEL E2517 AND MODEL E2503 POWER CONTROL PENCILS | Valleylab, Inc. | GEI | Class II | 1986-05-20 |
| K861636 | MIAMI-SUNNY | Sunworld Corp. | FTC | Class II | 1986-05-16 |
| K861705 | CORONA 3000 (DERMATOLOGIC ULTRAVIOLET LAMP) | Vita-Tan Corp. | FTC | Class II | 1986-05-16 |
| K861711 | SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE | Busse Hospital Disposables, Inc. | GDT | Class I | 1986-05-16 |
| K861570 | ALPHA TAN 1000 AND ALPHA TAN 1200 | Midwest Marketing Service | FTC | Class II | 1986-05-13 |
| K861447 | ALISUN -TYPE 1200, TYPE 1000/800 AND TYPE 700/900 | Southern Exposure, Inc. | FTC | Class II | 1986-05-13 |
| K861593 | TOPICAL HYPERBARIC OXYGEN CHAMBER | Stephenson Industries, Inc. | KPJ | Class II | 1986-05-12 |
| K861600 | SPUNGUARD PLUS SURGICAL GOWN | Kimberly-Clark Corp. | FYA | Class II | 1986-05-12 |
| K861528 | TECNOL PERSONAL SHOE COVER | Technol, Inc. | FXP | Class I | 1986-05-12 |
| K861139 | ADULT TDS ELECTROSURGICAL GROUNDING PAD (R.E.M.) | Conmedcorp | GEI | Class II | 1986-05-09 |
| K861533 | SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS | Sunfit, Inc. | FTC | Class II | 1986-05-08 |
| K861288 | NON-STERILE & STERILE DISPOSABLE SURGICAL DRAPES | Procedure Pak, Inc. | KKX | Class II | 1986-05-06 |
| K861525 | DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS | D & D Products, Inc. | FSM | Class I | 1986-05-06 |
| K861101 | THE NEW FLEXIBLE COLLAPSIBLE CHAMBER | Stephenson Industries, Inc. | KPJ | Class II | 1986-05-06 |
| K855084 | PREMIE T.D.S. ELECTROSURGICAL GROUNDING PAD | Conmedcorp | GEI | Class II | 1986-05-06 |
| K861036 | E7509 POLYHESIVE II PATIENT RETURN ELECTRODE | Valleylab, Inc. | GEI | Class II | 1986-05-06 |
| K854898 | ATLANTIC GRASPER | Euro-Med Intl. | KDC | Class I | 1986-05-02 |
| K861046 | MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA | Sharplan Industries, Inc. | LNK | Class II | 1986-05-02 |
| K860981 | ASPIR-VAC DISPOSABLE SURGICAL DRAIN SYSTEM | Sun Technologies | GCY | Class I | 1986-05-02 |
| K854231 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES | Clinical Technology Corp. | GEI | Class II | 1986-05-02 |
| K855210 | SURGICAL CARBON DIOXIDE LASER SYS. #20B ULTRALIGHT | Directed Energy, Inc. | GEX | Class II | 1986-05-02 |
| K854998 | SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC | Directed Energy, Inc. | GEX | Class II | 1986-05-02 |
| K854894 | SPOON | Euro-Med Intl. | KDC | Class I | 1986-05-02 |
| K854897 | MAX-I-GRASP | Euro-Med Intl. | KDC | Class I | 1986-05-02 |
| K854896 | HOOK SCISSOR | Euro-Med Intl. | KDC | Class I | 1986-05-02 |
| K854890 | HOOK PROBE | Euro-Med Intl. | KDC | Class I | 1986-05-02 |
| K854895 | BASKET FORCEP | Euro-Med Intl. | KDC | Class I | 1986-05-02 |
| K853878 | ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY | Endo Lase, Inc. | GEX | Class II | 1986-05-02 |
| K854891 | KNIFE | Euro-Med Intl. | EMF | Class I | 1986-05-02 |
| K854901 | PACIFIC GRASPER | Euro-Med Intl. | KDC | Class I | 1986-05-02 |
| K860479 | GREEN-LINE BIPOLAR COAGULATION UNIT | Grieshaber & Co. | GEI | Class II | 1986-05-01 |
| K861196 | STERILE STOCKINETTE W/ANTIMICROBIAL AGENT | Deroyal Industries, Inc. | KKX | Class II | 1986-04-30 |
| K861265 | DIALET LANCING DEVICE | Home Diagnostics, Inc. | FMK | Class II | 1986-04-30 |
| K860811 | ZEISS VOICE CONTROL SYSTEM FOR OPMI'S | Carl Zeiss, Inc. | EPT | Class I | 1986-04-30 |
| K861243 | NEONATAL UNILET | Ulster Scientific, Inc. | FMK | Class II | 1986-04-29 |
| K861107 | TAN MATE HOME TANNING UNIT | Specialty Engineering, Inc. | FTC | Class II | 1986-04-25 |
| K861405 | REPLACEMENT HOSES | Micro-Aire Surgical Instruments, Inc. | HSZ | Class I | 1986-04-25 |
| K860087 | SHARPLAN MODEL 1020 CO2 SURGICAL LASER SYSTEM | Sharplan Lasers, Inc. | GEX | Class II | 1986-04-24 |
| K860273 | MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY | Britt Corp., Inc. | GEX | Class II | 1986-04-23 |
| K852436 | AMBULASE | Xanar, Inc. | GEX | Class II | 1986-04-18 |
| K861285 | SKIN MESH DEVICE | Precision Modified Devices | GFD | Class I | 1986-04-17 |
| K861151 | SUEL BLOOD LANCET | Exel Intl. | FMK | Class II | 1986-04-15 |
| K860278 | MODEL 525-25 WATT CO2 LASER FOR DERMA/PLASTIC | Britt Corp., Inc. | GEX | Class II | 1986-04-15 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.