Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 49
- Latest Decision
- 1983-12-27
Clearances · page 149 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K833638 | DERMATEX STERILE FINGER BANDAGE | Dermatec, Inc. | NAD | Class I | 1983-12-27 |
| K833785 | EMERGENCY ASPIRATOR | Vitalograph , Ltd. | BTA | Class II | 1983-12-22 |
| K833816 | HEMASTICK 1-1.5 & 2-DISPOS. BLOOD | Medprobe Laboratories | FMK | Class II | 1983-12-22 |
| K833480 | MOLECTRON MEDICAL ND:YAG LASER, MODEL 8000 | Cooper Lasersonics, Inc. | LNK | Class II | 1983-12-21 |
| K832151 | PDM SILOXANE PROSTHETIC ORBIT | Delaware Prosthetics, Inc. | GBI | Class I | 1983-12-19 |
| K833717 | PADGETT SUCTION CANNULA | Advanced Biosearch Assn. | GEA | Class I | 1983-12-14 |
| K831841 | STERILE DISP. INSTRUMENT TRAYS | E.M. Adams | KDD | Class I | 1983-12-14 |
| K833093 | VANISH II | Warner-Lambert Co. | KGO | Class I | 1983-12-12 |
| K833059 | SUCTION CATHETER TRAYS | Intermed, Inc. | GBZ | Class I | 1983-12-12 |
| K831489 | SURGICAL TUBE HOLDER | The Urology Group | GEI | Class II | 1983-12-12 |
| K832978 | MENISCAL SUTURE GUN | Instrument Makar, Inc. | GDF | Class I | 1983-12-12 |
| K833357 | VYDAX 525-550 & 5100 FLUOROTELOMER | ETHICON, Inc. | GDT | Class I | 1983-12-12 |
| K832908 | COMFEEL PROTECTIVE RINGS | Coloplast A/S | EYF | Class I | 1983-12-12 |
| K833812 | SUPERJET DISPOSABLE BLOOD LANCET | Medrobe Laboratories | FMK | Class II | 1983-12-12 |
| K832153 | PDM SILOXANE PROSTHETIC NOSE | Delaware Prosthetics, Inc. | GBI | Class I | 1983-12-09 |
| K832152 | PDM SILOXANE PROSTHETIC EAR | Delaware Prosthetics, Inc. | GBI | Class I | 1983-12-09 |
| K833449 | HAND CONTROLLED PENCIL OR SWITCH HAND | Cameron-Miller, Inc. | GEI | Class II | 1983-11-29 |
| K833648 | OPHTHALMIC CAUTERY #6821-HOT-TEMP #'S | Edward Weck, Inc. | HAM | Class II | 1983-11-29 |
| K833364 | 3M SCOTCHPLATE II DISPERSIVE ELECTRODE | 3M Company | GEI | Class II | 1983-11-29 |
| K833441 | DRY GEL | Concept, Inc. | GEI | Class II | 1983-11-29 |
| K833541 | SURGICAL INSTRUMENT | Hirata Sangyo Co. USA, Inc. | GAD | Class I | 1983-11-28 |
| K833542 | SURGICAL INSTRUMENT | Hirata Sangyo Co. USA, Inc. | GEN | Class I | 1983-11-28 |
| K833549 | PDI SURGICAL SCRUB/BRUSH T150-70 | Nice-Pak Products, Inc. | NAB | Class I | 1983-11-28 |
| K832148 | PDM SILOXANE PROSTHETIC CHIN IMPLANT | Delaware Prosthetics, Inc. | FWP | Class II | 1983-11-28 |
| K833509 | CHEMONUCLEOLYSIS TABLE | Stryker Corp. | FWY | Class I | 1983-11-28 |
| K831204 | MULTIPLE | Derma-Lock Medical Corp. | NAD | Class I | 1983-11-28 |
| K833624 | SHUTT UNIVERSAL STRESS POST | Concept, Inc. | FWZ | Class I | 1983-11-28 |
| K833344 | AUTO-LANCET | Palco Laboratories, Inc. | FMK | Class II | 1983-11-07 |
| K832368 | CHANGING METHOD OF STERILITY RELEASE | Devon Industries, Inc. | EMF | Class I | 1983-10-31 |
| K832416 | AXIOM HYDROMER WOUND DRAINS | Axiom Medical, Inc. | GBS | Class I | 1983-10-31 |
| K831912 | ROUND-BEEHIVE- DISSECTORS 3/8 | Ormed Mfg., Inc. | GDI | Class I | 1983-10-31 |
| K833187 | HALL OSTEON | Amsco Co. | GET | Class I | 1983-10-31 |
| K831454 | LASTOBAND ADHESIVE BANDAGES | Smith & Nephew, Inc. | NAD | Class I | 1983-10-31 |
| K832318 | ISOLATION BAG 3M | 3M Company | KGY | Class I | 1983-10-31 |
| K831914 | STRUNG NEURO SPONGE PATTIES-X-RAY- | Ormed Mfg., Inc. | GDY | Class I | 1983-10-31 |
| K831825 | DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM | Hospitak, Inc. | KPJ | Class II | 1983-10-27 |
| K832520 | SUCTION TIPS | Wells Johnson Co. | GEA | Class I | 1983-10-20 |
| K832521 | PLASTIC SUCTION TIPS | Wells Johnson Co. | GEA | Class I | 1983-10-20 |
| K832274 | ASPIRATOR | Wells Johnson Co. | BTA | Class II | 1983-10-20 |
| K832899 | ZIMMER OSSIMETER | Zimmer, Inc. | FTY | Class I | 1983-10-14 |
| K831287 | E-Z FIT | Triad Medical Division | KKX | Class II | 1983-10-14 |
| K832680 | MICRO-EDGE DISPOSABLE BLADES | Micromedics, Inc. | KDC | Class I | 1983-10-14 |
| K832626 | TOP STERILE DISPOS. HYPODERMIC NEEDLES | Top Surgical Manufacturers Co. | GAA | Class I | 1983-10-14 |
| K832636 | FRAZIER SUCTION INSTRUMENT-DISPOS | Pilling Co. | GEA | Class I | 1983-10-14 |
| K833015 | BIOPLAR CORD -DISPOSABLE 30-1538 | Codman & Shurtleff, Inc. | GEI | Class II | 1983-10-14 |
| K831931 | ATRIUM THORACIC CATHETER | Atrium Medical Corp. | GBZ | Class I | 1983-10-04 |
| K832100 | PSI SURGICAL ASPIRATOR | Advanced Biosearch Assn. | BTA | Class II | 1983-10-04 |
| K830800 | C-LOOPS | Concept, Inc. | KDC | Class I | 1983-10-04 |
| K832887 | ELECTRONIC UNIT | Surgi-Quip Inc.U | EPT | Class I | 1983-10-04 |
| K831512 | DOSIMETRY RELEASE OF RADIATION STERILIZ | Biomet, Inc. | JDK | Class II | 1983-09-29 |
| K831756 | ANSPACH 65,000 | The Anspach Effort, Inc. | HSZ | Class I | 1983-09-29 |
| K832278 | LIGHT HANDLE COVER | Concept, Inc. | KKX | Class II | 1983-09-29 |
| K832709 | SKIN STAPLING DEVICE SC2000 | Prosper, Inc. | GDT | Class I | 1983-09-26 |
| K831842 | DRAVON T CLAMP | Dravon Medical, Inc. | KDC | Class I | 1983-09-26 |
| K832874 | ISOVIS WOUND PROTECTOR | Ritmed, Inc. | KKX | Class II | 1983-09-26 |
| K831913 | COLOR-EZE PRE-WASHED LAP SPONGES | Ormed Mfg., Inc. | GDY | Class I | 1983-09-26 |
| K830001 | SUPERJET BTD BLEEDING TIME DEVICE DISP | Medprobe Laboratories | FMK | Class II | 1983-09-26 |
| K832768 | S & W SW52E W/POWER BACK LIFT | S & W Enterprises, Inc. | LGX | Class I | 1983-09-20 |
| K832472 | ELEVATOR CUSHION | Inmed Corp. | FWZ | Class I | 1983-09-20 |
| K831764 | URIAS PRESSURE SPLINTS, & FIRST AID | Svenol Andersen | FZF | Class I | 1983-09-12 |
| K832047 | STERILE SUTURE REMOVAL SET | Ormed Mfg., Inc. | KDD | Class I | 1983-09-12 |
| K831664 | PLASTIC THUMB FORCEPS | Medcare Products | KDC | Class I | 1983-09-12 |
| K832385 | CRYOPROBES MC-1400-CRYOSURG-CONSOLE | Spembly Medical , Ltd. | GEH | Class II | 1983-09-12 |
| K831886 | FEMORAL CANAL SPONGE | Zimmer, Inc. | NAB | Class I | 1983-09-12 |
| K831911 | DISPOSABLE FLOOR INSTRUMENTS | Ormed Mfg., Inc. | KDC | Class I | 1983-09-12 |
| K831665 | DISPOSABLE NEEDLE HOLDER | Medcare Products | KDC | Class I | 1983-09-12 |
| K831915 | SAFETY PINS & RUBBER BANDS | Ormed Mfg., Inc. | KDC | Class I | 1983-09-12 |
| K832342 | ENDOSCOPIC CAMERA TV W/AUDIO | Kamiya Tsusan Kaisha, Ltd. | KQM | Class I | 1983-09-12 |
| K831795 | FIRST AID KITS | I M, Inc. | KDD | Class I | 1983-09-01 |
| K832301 | DIRECT BONDED BRACKET REMOVER | Northwest Orthopedics | JCX | Class II | 1983-08-31 |
| K831661 | DISPOSABLE SCISSORS | Medcare Products | KDC | Class I | 1983-08-25 |
| K831648 | ANCHOR BRAND SURGICAL NEEDLES | Anchor Products Co. | GAB | Class I | 1983-08-16 |
| K831725 | FOIL IN 3 FORMS-NON-STERILE SHEETS | S. Jackson, Inc. | FTM | Class II | 1983-08-16 |
| K832172 | GAUZE SPONGE X-RAY DETECTABLE- | Sudreca Surgical Dressings, Inc. | GDY | Class I | 1983-08-12 |
| K831727 | QUARTER GLOBE CAPS | S. Jackson, Inc. | FTM | Class II | 1983-08-12 |
| K832186 | HALL DRILL/REAMER | Amsco Co. | GET | Class I | 1983-08-12 |
| K832281 | TWO-PLY PAPER FACE FACE MASK | Abco Dealers, Inc. | FXX | Class II | 1983-08-12 |
| K832187 | HALL OSCILLATOR | Amsco Co. | GET | Class I | 1983-08-12 |
| K832340 | OPERATING ROOM TABLES HYDRAULIC | Kamiya Tsusan Kaisha, Ltd. | BWN | Class I | 1983-08-12 |
| K832334 | CRYOMEDICS 5000 CRYOSURGICAL CONSOLE | Spembly Medical , Ltd. | GEH | Class II | 1983-08-12 |
| K831086 | CEILING MOUNTED SUPPORT | Amsco Co. | FQO | Class I | 1983-08-12 |
| K831282 | BANDAGE COMPRESS | Pac-Kit Safety Equipment Co. | NAB | Class I | 1983-08-12 |
| K832137 | CONVERTORS FLASH STERILIZING TRAY | American Convertors Div., American Pharmaseal | FSM | Class I | 1983-08-12 |
| K831281 | GAUZE COMPRESS | Pac-Kit Safety Equipment Co. | NAB | Class I | 1983-08-12 |
| K831724 | CHIN (MENTOPLASTY) IMPLANTS | S. Jackson, Inc. | FWP | Class II | 1983-08-12 |
| K832140 | CRYOMEDICS 5000 CRYOPROBES | Spembly Medical , Ltd. | GEH | Class II | 1983-08-12 |
| K831048 | TUFCOTE EPILATION PROBE | Serapis Medical Electronics, Co. | KCW | Class I | 1983-08-12 |
| K831723 | SUPRAMID EXTRA SURGICAL MESH | S. Jackson, Inc. | FTM | Class II | 1983-08-12 |
| K832188 | HALL RECIPROCATOR | Amsco Co. | GET | Class I | 1983-08-12 |
| K831283 | TRIANGLE BANDAGE STERILE | Pac-Kit Safety Equipment Co. | NAD | Class I | 1983-08-12 |
| K831284 | GAUZE BANDAGE | Pac-Kit Safety Equipment Co. | NAB | Class I | 1983-08-12 |
| K831726 | EYE MUSCLE SLEEVES | S. Jackson, Inc. | FTM | Class II | 1983-08-11 |
| K831457 | AUTO SUTURE POLY SURGICLIP HEMOSTATIC | United States Surgical, A Division of Tyco Healthc | FZP | Class II | 1983-08-08 |
| K831453 | SILCATH CENTRAL CATHETER TRAY W/18 GA | Argon Medical Corp. | JCY | Class I | 1983-07-28 |
| K832157 | DELTA CONDUCTIVE ADHESIVE ELECTROSURG- | Delta Medical Electronics, Inc. | GEI | Class II | 1983-07-26 |
| K832194 | SURGICAL FACE MASK-DISPOSABLE | Tecnol New Jersey Wound Care, Inc. | FXX | Class II | 1983-07-26 |
| K831798 | DISPOSABLE SCALPELS | I M, Inc. | KDC | Class I | 1983-07-19 |
| K831797 | HEMOSTATS | I M, Inc. | HRQ | Class I | 1983-07-19 |
| K831565 | MICRO-THIN SURGICAL GLOVE | Ansell, Inc. | KGO | Class I | 1983-07-19 |
| K831662 | DISPOSABLE HEMOSTAT (STRAIGHT&CURVED | Medcare Products | KDC | Class I | 1983-07-19 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.