GAXClass I

Tourniquet, Nonpneumatic

21 CFR 878.5900 / General, Plastic Surgery

GAX is the FDA product code for Tourniquet, Nonpneumatic, a class I device type, regulated under 21 CFR 878.5900. As of 2026-09-10, FDA records hold 20 510(k) clearances under this code, the most recent dated 1993-09-01, and 8 recalls.

Classification record

Product code: GAX
Device name: Tourniquet, Nonpneumatic
Regulation: 21 CFR 878.5900
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: 20
Ingested recalls: 8

Clearances, product code GAX

By decision year

20 clearances under product code GAX with a decision year between 1978 and 1993, 1985 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code GAX by decision year
Year	Clearances
1978	2
1979	1
1981	1
1982	2
1983	1
1984	2
1985	4
1987	3
1988	3
1993	1

Applicants with the most clearances

Product code GAX

Applicants holding the most 510(k) clearances under product code GAX
Applicant	Clearances
Abco Dealers, Inc.	2
Barretta Products, Research and Development, Inc.	1
Boehringer Ingelheim Pharmaceuticals, Inc.	1
Conphar, Inc.	1
Cp Medical	1
Dale Medical Products, Inc.	1
Degania Silicone, Inc.	1
Dryden Corp.	1
Hemox, Inc.	1
Icat Systems	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 318 companies shown, in name order