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FDA Product Code

FDA Product Code FZX — Clearance Directory

Device Class
Class I
21 CFR Citation
878.4800

510(k) Clearances — 19 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K914715 PARALLELING GUIDES Implant Corp. of America 1994-02-16 Traditional PDF ↗
K871413 CIVCO STEPPER CIVCO Medical Instruments Co., Inc. 1987-07-14 Traditional PDF ↗
K871503 BIOPSY NEEDLE GUIDE KIT, STERILE Amedic USA 1987-07-10 Traditional PDF ↗
K862564 A.C.L. GUIDE KIT Aspen Laboratories, Inc. 1986-08-18 Traditional PDF ↗
K854262 MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY Meadox Surgimed, Inc. 1985-12-24 Traditional PDF ↗
K852402 NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER North American Instrument Corp. 1985-07-11 Traditional PDF ↗
K842698 BRITISH SPINAL FUSION SET Downs Surgical , Ltd. 1984-09-12 Traditional PDF ↗
K841618 THREADING TUBE Plastafil, Inc. 1984-08-27 Traditional PDF ↗
K841619 DRILL GUIDE Plastafil, Inc. 1984-07-11 Traditional PDF ↗
K841297 TECHMEDICA DRILL GUIDE Techmedica, Inc. 1984-04-25 Traditional PDF ↗
K840835 STRAITH DRAIN INSERTER Surgical Technology Laboratories, Inc. 1984-04-23 Traditional PDF ↗
K834350 ACUFEX DREZ COMMUNICATING DRILL GUIDE Acufex Microsurgical, Inc. 1984-03-19 Traditional PDF ↗
K830720 GRAF MENISCAL SUTURE SET Acufex Microsurgical, Inc. 1983-06-16 Traditional PDF ↗
K821618 DISPOSABLE NEEDLE HOLDERS Medcare Products 1982-06-21 Traditional PDF ↗
K810888 BOUNDARY TUBING HOLDERS The Buckeye Cellulose Corp. 1981-04-23 Traditional PDF ↗
K810788 SURGICAL TUBE HOLDER The Urology Group 1981-04-17 Traditional PDF ↗
K802093 GABBAY-FRATER SUTURE GUIDE Howmedica Corp. 1980-09-26 Traditional PDF ↗
K792468 FEEDING TUBE PLACEMENT STYLET Biosearch Medical Products, Inc. 1979-12-27 Traditional PDF ↗
K790872 ENTERIC TUBE GUIDE Biosearch Medical Products, Inc. 1979-05-23 Traditional PDF ↗

Product code FZX · Class I · General, Plastic Surgery. Data: openFDA.