Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 54
- Latest Decision
- 1983-07-14
Clearances · page 150 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K831805 | GENERAL SURGICAL INSTRUMENTS | Aim Corp. | GEN | Class I | 1983-07-14 |
| K831392 | TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709 | Travenol Laboratories, S.A. | GAA | Class I | 1983-07-12 |
| K831128 | BARD INTRAMEDULLARY PLUG | C.R. Bard, Inc. | JDK | Class II | 1983-07-12 |
| K831952 | SURGICAL APPAREL SHOE COVERS | Sudreca Surgical Dressings, Inc. | BWP | Class I | 1983-07-12 |
| K831772 | GUILLOTINE BLADE | Ortho Pared Instruments, Inc. | HTZ | Class I | 1983-07-07 |
| K831714 | MICRO-AIRE REPLACEMENT SURG. SAW BLADE | Micro-Aire Surgical Instruments, Inc. | GFA | Class I | 1983-07-07 |
| K831831 | TRULIFE SILICONE BREAST FORM | Medeering, Ltd. | GBI | Class I | 1983-06-30 |
| K831675 | TWIST LOCK DRILL 1120 | Micro-Aire Surgical Instruments, Inc. | GET | Class I | 1983-06-30 |
| K831372 | TLS SURGICAL MARKER | Porex Medical | FZZ | Class I | 1983-06-24 |
| K831041 | SAGITTAL KNEE TESTER | Orthopedic Systems, Inc. | FTY | Class I | 1983-06-24 |
| K831508 | MALIS CMC-II BIPOLAR COAGULATOR & CUT | Valley Forge Scientific Corp. | GEI | Class II | 1983-06-24 |
| K830270 | ISOVIS WOUND PROTECTOR | Ritmed, Inc. | KKX | Class II | 1983-06-24 |
| K831611 | UNI-THANE | Carapac Systems, Inc. | NAD | Class I | 1983-06-20 |
| K830720 | GRAF MENISCAL SUTURE SET | Acufex Microsurgical, Inc. | FZX | Class I | 1983-06-16 |
| K823552 | APPOSE SKIN STAPLER & REMOVER | American Cyanamid Co. | GDW | Class II | 1983-06-15 |
| K821178 | ETHICON EXTERNAL FIXATION WIRE | ETHICON, Inc. | FYI | Class I | 1983-06-11 |
| K831488 | DAVRON PROF. SCRUB BRUSH-DRY/STERILE | Minnetonka, Inc. | GEC | Class I | 1983-06-08 |
| K831451 | SILCATH CENTRAL CATHETER TRAY SIZE- | Argon Medical Corp. | JCY | Class I | 1983-06-08 |
| K831085 | SYNEVAC VACUUM SOURCE UNIT | Synemed, Inc. | BTA | Class II | 1983-06-08 |
| K830123 | DISP. YANKAVER SURG. SUCTION INSTRUMENT | Narco Scientific | GCY | Class I | 1983-06-08 |
| K831340 | DRAIN-R-DRAPE(EYE | Sur-Tech, Inc. | HMT | Class II | 1983-06-08 |
| K831290 | ELECTRODE, FLEXIBLE SUCTION COAGULATOR | Aspen Laboratories, Inc. | GEI | Class II | 1983-06-03 |
| K830272 | PROTET HOLDERS-BLOCKS & ROLL | Ritmed, Inc. | FWZ | Class I | 1983-06-03 |
| K831325 | NUTROMAT | Medlog GmbH Marketing Services | GBB | Class I | 1983-06-02 |
| K831357 | BOUNDARY HEADWEAR | Procter & Gamble Mfg. Co. | FYF | Class I | 1983-06-02 |
| K831385 | LITHOTOMY CHAIR #415 | Midmark Corp. | GBB | Class I | 1983-06-02 |
| K831299 | EVEN-TEMP. CAPACITIVE ADHESIVE PAD | Delta Medical Electronics, Inc. | GEI | Class II | 1983-06-02 |
| K830926 | 160/260 SUCTION COAGULATOR | Zimmer, Inc. | GEI | Class II | 1983-06-02 |
| K831236 | BIPOLAR CARD | New England Surgical Instrument Corp. | GEI | Class II | 1983-06-02 |
| K830298 | ACCU-LINE SURGICAL MARKER | Accu-Line | FZZ | Class I | 1983-06-02 |
| K830050 | MOLNLYCKE MEPORE STERILE SELF-ADHESIVE | Lada Intl., Inc. | NAD | Class I | 1983-06-02 |
| K831291 | ELECTROSURGICAL UNIT-MF 380 #60-1700 | Aspen Laboratories, Inc. | GEI | Class II | 1983-06-02 |
| K830585 | ANVIL RETRACTOR | Twin City Surgical, Inc. | GAD | Class I | 1983-05-27 |
| K831367 | PMN VOLZ CURETTES | 3M Company | FZS | Class I | 1983-05-25 |
| K831138 | CURVED HEMOSTAT 5 | Almore Intl., Inc. | HTD | Class I | 1983-05-18 |
| K831007 | CONNECTING TUBES | Medovations, Inc. | BTA | Class II | 1983-05-18 |
| K831137 | STRAIGHT 5 HEMOSTAT | Almore Intl., Inc. | HTD | Class I | 1983-05-18 |
| K831207 | SPUNGUARD SCRUB SUIT | Kimberly-Clark Corp. | FXO | Class I | 1983-05-16 |
| K831042 | CHEMONUCLEOLYSIS TABLE EXTENSION | Orthopedic Systems, Inc. | FSE | Class I | 1983-05-16 |
| K831226 | MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450 | Ballard Medical Products | GEC | Class I | 1983-05-16 |
| K830374 | RESCUE PACK | Akla, Inc. | KDD | Class I | 1983-05-13 |
| K830925 | MF 380 ELECTROSURGICAL UNIT | Zimmer, Inc. | GEI | Class II | 1983-05-13 |
| K830259 | PROTET SOAP & WASH MITT | Ritmed, Inc. | GED | Class I | 1983-05-09 |
| K831119 | LUO CURRETTES #3211 | Pmt, Inc. | FZS | Class I | 1983-05-09 |
| K830889 | DEXON 'S' POLYGLYCOLIC ACID MESH | Davis & Geck, Inc. | FTM | Class II | 1983-05-09 |
| K830993 | AMPLIGREFFE | Prothia USA, Inc. | GFD | Class I | 1983-05-03 |
| K830707 | ACUFEX UNIVERSAL LEG HOLDER | Acufex Microsurgical, Inc. | FWZ | Class I | 1983-05-02 |
| K830510 | BBL STREP GROUPING KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | GCY | Class I | 1983-05-02 |
| K830859 | I/A KIT | Surgeon Surgical Instrumentation, Inc. | GBX | Class I | 1983-05-02 |
| K830711 | TRACHESTOMY & NASAL SUCTIONING KIT #- | Intertex Medical | GBZ | Class I | 1983-05-02 |
| K830607 | SUCTION RESERVOIR | Sil-Med Corp. | GCY | Class I | 1983-05-02 |
| K830703 | GLOMARK | Alphamedix, Inc. | FZZ | Class I | 1983-04-28 |
| K830890 | SURGICAL FACE MASK | Busse Hospital Disposables, Inc. | FXX | Class II | 1983-04-27 |
| K830532 | ELECTROSURGICAL CAULTERY PENCIL | American V. Mueller | GEI | Class II | 1983-04-27 |
| K830821 | MICRO-MITT | CooperVision, Inc. | FXP | Class I | 1983-04-27 |
| K830473 | NOVA GAUZE | American Threshold Industries, Inc. | NAB | Class I | 1983-04-15 |
| K830704 | ONE TIME DISPOSABLE SKIN STAPLER | Acme United Corp. | FZQ | Class I | 1983-04-12 |
| K830339 | IMSI/METRIPOND HAND OPERATING TABLE | Intl. Management Services, Inc. | FSE | Class I | 1983-04-12 |
| K822096 | CHEMOTHERAPY INFUSION CATHETER | American Heyer Schulte | JCY | Class I | 1983-04-12 |
| K830723 | REDI-DRAPE | The Oec Group | KKX | Class II | 1983-04-12 |
| K830199 | AUTO SUTURE TA DISPOS-STAPLE CART | United States Surgical, A Division of Tyco Healthc | GDW | Class II | 1983-04-12 |
| K830613 | ELECTROSURGICAL GROUND PAD-DISPERSIVE | Con Med Equipment, Inc. | GEI | Class II | 1983-04-12 |
| K830949 | POLYETHYLENE MEDULLARY PLUG - STIIHMER/ | Allo Pro Corp. | LZN | Class II | 1983-04-12 |
| K830721 | WIRE TWISTERS | The Anspach Effort, Inc. | HTC | Class I | 1983-04-12 |
| K830745 | ADT DISPOSABLE SCALPEL W/STAINLESS STEEL | Lab Industries, Inc. | GDX | Class I | 1983-04-12 |
| K830434 | DISPOSABLE INTRA-ARTICULAR BLADE | Concept, Inc. | GFA | Class I | 1983-04-12 |
| K830768 | DISPOSABLE SKIN STAPLER | Surgeons Choice, Inc. | FZQ | Class I | 1983-04-12 |
| K830219 | VARIOUS INSTRUMENTS & INSTRUMENT TRAYS | Ascep, Inc. | FSM | Class I | 1983-04-12 |
| K830593 | ENSURE DRESSING | Warner-Lambert Co. | NAD | Class I | 1983-04-06 |
| K830394 | PROVIDONE-IODINE PREP-PADS & TOWELETTES | H & P Industries, Inc. | GEC | Class I | 1983-04-06 |
| K830393 | PROVIDONE-IODINE SWABSTICKS | H & P Industries, Inc. | GEC | Class I | 1983-04-06 |
| K830822 | EYE DRAPE | CooperVision, Inc. | HMT | Class II | 1983-04-06 |
| K823854 | MEDCARE SUTURE REMOVAL TRAYS | Medcare Products | FSM | Class I | 1983-03-31 |
| K830467 | TOURNIQUET/LATEX TOURNIQUET | Primeline Industries, Inc. | GAX | Class I | 1983-03-31 |
| K830610 | FLAT SUCTION DRAIN | Sil-Med Corp. | GBC | Class II | 1983-03-29 |
| K830612 | CHEMO-TABLE | Fabrications Unltd. | FWZ | Class I | 1983-03-29 |
| K830545 | DISPERSIVE ELECTRODE | C.R. Bard, Inc. | GEI | Class II | 1983-03-29 |
| K830378 | STERILE, DISPOSABLE, HYPODERMIC NEEDLES | Abco Dealers, Inc. | GAA | Class I | 1983-03-24 |
| K830675 | ORAL SPONGE | Unisplint Corp. | GEO | Class I | 1983-03-24 |
| K830189 | CARDIOVASCULAR SAW BLADES | Temp Medical Products, Inc. | DWH | Class I | 1983-03-24 |
| K823905 | SURGICAL BLADES | Designs IN Medicine | GEI | Class II | 1983-03-24 |
| K830660 | STERILE SURGICAL DRAPES | Phoenix Glove Co. | KKX | Class II | 1983-03-17 |
| K830511 | ZANLEX, ZAN-TEX & ZANDEX | Winn Hirsch & Assoc. | GDY | Class I | 1983-03-17 |
| K830260 | FLORET VAGINAL PACKING/TAMPONS | Ritmed, Inc. | GDY | Class I | 1983-03-17 |
| K823852 | CHESEBROUGH-POND'S MULTILAYER ELASTIC | Chesebrough-Pond'S U.S.A. Co. | NAD | Class I | 1983-03-17 |
| K823879 | COVER-ROLL STRETCH | Beiersdorf, Inc. | NAB | Class I | 1983-03-09 |
| K830287 | ZIMMER SKIN PROTECTOR | Zimmer, Inc. | GAD | Class I | 1983-03-09 |
| K830248 | DEVO'N LOOPS | Devon Industries, Inc. | KDC | Class I | 1983-03-08 |
| K830089 | BURN DRESSING | Action Medical Systems, Inc. | NAD | Class I | 1983-03-08 |
| K830277 | DUOWIPE CAUTERY TIP & INSTRUMENT CLEANER | Ritmed, Inc. | GEI | Class II | 1983-03-08 |
| K830503 | LIGACLIP TITANIUM LIGATING CLIP | ETHICON, Inc. | FZP | Class II | 1983-03-08 |
| K830153 | RICHARDS INTRA-ARTICULAR SHAVER BLADES | Richard'S Medical Equip., Inc. | GEY | Class I | 1983-02-28 |
| K830326 | NEGATIVE PRESSURE ARTERIAL BLOOD LINE | Erika, Inc. | KDC | Class I | 1983-02-28 |
| K830201 | POLYESTER X-RAY DETECTABLE STRUNG-SPONGE | American Medical Disposable, Inc. | GDY | Class I | 1983-02-23 |
| K830235 | FRANZEN NEEDLE GUIDE | Precision Dynamics Corp. | GDM | Class I | 1983-02-23 |
| K830202 | COTTON BALLS, X-RAY OPAQUED STRUNG & NON | American Medical Disposable, Inc. | GDY | Class I | 1983-02-23 |
| K823923 | MF 360B ELECTROSURGICAL UNIT | Aspen Laboratories, Inc. | GEI | Class II | 1983-02-15 |
| K830166 | MOLNLYCKE ETE STERILE NON-ADHERENT DRESS | Lada Intl., Inc. | NAB | Class I | 1983-02-09 |
| K823755 | BICEPS ELECTROCAUTERY SYSTEM | Squibb Diagnostics | HAM | Class II | 1983-01-26 |
| K830010 | SUPERJET LANCET | Medprobe Laboratories | FMK | Class II | 1983-01-26 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.