FZXClass I

Guide, Surgical, Instrument

21 CFR 878.4800 / General, Plastic Surgery

FZX is the FDA product code for Guide, Surgical, Instrument, a class I device type, regulated under 21 CFR 878.4800. As of 2026-09-10, FDA records hold 19 510(k) clearances under this code, the most recent dated 1994-02-16, and 29 recalls.

Classification record

Product code: FZX
Device name: Guide, Surgical, Instrument
Regulation: 21 CFR 878.4800
Device class: Class I
Review panel: General, Plastic Surgery
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 19
Ingested recalls: 29

Clearances, product code FZX

By decision year

19 clearances under product code FZX with a decision year between 1979 and 1994, 1984 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code FZX by decision year
Year	Clearances
1979	2
1980	1
1981	2
1982	1
1983	1
1984	6
1985	2
1986	1
1987	2
1994	1

Applicants with the most clearances

Product code FZX

Applicants holding the most 510(k) clearances under product code FZX
Applicant	Clearances
Acufex Microsurgical, Inc.	2
Biosearch Medical Products, Inc.	2
Plastafil, Inc.	2
Amedic USA	1
Aspen Laboratories, Inc.	1
CIVCO Medical Instruments Co., Inc.	1
Downs Surgical, Ltd.	1
Howmedica Corp.	1
Implant Corp. of America	1
Meadox Surgimed, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 480 companies shown, in name order