Product code FZX— General, Plastic Surgery

FDA has cleared 19 devices under product code FZX between 1979 and 1994, filed by 16 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19941 clearance
• 19872 clearances
• 19861 clearance
• 19852 clearances
• 19846 clearances
• 19831 clearance
• 19821 clearance
• 19812 clearances
• 19801 clearance
• 19792 clearances

• Plastafil, Inc.2 clearances
• Biosearch Medical Products, Inc.2 clearances
• Acufex Microsurgical, Inc.2 clearances
• The Urology Group1 clearance
• The Buckeye Cellulose Corp.1 clearance
• Techmedica, Inc.1 clearance
• Surgical Technology Laboratories, Inc.1 clearance
• North American Instrument Corp.1 clearance
• Medcare Products1 clearance
• Meadox Surgimed, Inc.1 clearance

Injury

797

Malfunction

3,815

Total

4,612

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K914715 — PARALLELING GUIDESImplant Corp. of America·1994-02-16
• K871413 — CIVCO STEPPERCIVCO Medical Instruments Co., Inc.·1987-07-14
• K871503 — BIOPSY NEEDLE GUIDE KIT, STERILEAmedic USA·1987-07-10
• K862564 — A.C.L. GUIDE KITAspen Laboratories, Inc.·1986-08-18
• K854262 — MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLYMeadox Surgimed, Inc.·1985-12-24
• K852402 — NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZERNorth American Instrument Corp.·1985-07-11
• K842698 — BRITISH SPINAL FUSION SETDowns Surgical , Ltd.·1984-09-12
• K841618 — THREADING TUBEPlastafil, Inc.·1984-08-27
• K841619 — DRILL GUIDEPlastafil, Inc.·1984-07-11
• K841297 — TECHMEDICA DRILL GUIDETechmedica, Inc.·1984-04-25
• K840835 — STRAITH DRAIN INSERTERSurgical Technology Laboratories, Inc.·1984-04-23
• K834350 — ACUFEX DREZ COMMUNICATING DRILL GUIDEAcufex Microsurgical, Inc.·1984-03-19
• K830720 — GRAF MENISCAL SUTURE SETAcufex Microsurgical, Inc.·1983-06-16
• K821618 — DISPOSABLE NEEDLE HOLDERSMedcare Products·1982-06-21
• K810888 — BOUNDARY TUBING HOLDERSThe Buckeye Cellulose Corp.·1981-04-23
• K810788 — SURGICAL TUBE HOLDERThe Urology Group·1981-04-17
• K802093 — GABBAY-FRATER SUTURE GUIDEHowmedica Corp.·1980-09-26
• K792468 — FEEDING TUBE PLACEMENT STYLETBiosearch Medical Products, Inc.·1979-12-27
• K790872 — ENTERIC TUBE GUIDEBiosearch Medical Products, Inc.·1979-05-23