GZXClass I

Instrument, Microsurgical

21 CFR 882.4525 / Neurology

GZX is the FDA product code for Instrument, Microsurgical, a class I device type, regulated under 21 CFR 882.4525. As of 2026-09-10, FDA records hold 13 510(k) clearances under this code, the most recent dated 1993-07-20, and one recall.

Classification record

Product code: GZX
Device name: Instrument, Microsurgical
Regulation: 21 CFR 882.4525
Device class: Class I
Review panel: Neurology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 13
Ingested recalls: 1

Clearances, product code GZX

By decision year

13 clearances under product code GZX with a decision year between 1981 and 1993, 1985 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code GZX by decision year
Year	Clearances
1981	1
1983	1
1985	4
1986	1
1987	2
1989	1
1991	1
1993	2

Applicants with the most clearances

Product code GZX

Applicants holding the most 510(k) clearances under product code GZX
Applicant	Clearances
Keeler Instruments, Inc.	4
Downs Surgical, Ltd.	2
American Russian Medical Services, Inc.	1
American V. Mueller	1
Clarus Medical Systems, Inc.	1
Cordis US Corp.	1
Kinetic Medical Products	1
O.R. Specialties, Inc.	1
Prothia USA, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 130 companies shown, in name order