Product Code: GAX FDA class 1 21 CFR 878.5900

Tourniquet, Nonpneumatic

General, Plastic Surgery

The Tourniquet, Nonpneumatic (product code GAX) is a non-pneumatic device applied to an extremity to occlude blood flow to a limb during surgical procedures, using mechanical rather than air-pressure-based compression. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.5900 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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510(k)s

FEI Numbers

335

Registration Numbers

335

Unique Applicants

Years Active

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Basic Information

Product Code: GAX
Device Class: FDA class 1
Regulation Number: 878.5900
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K931198	UNIQUET	Sep 01, 1993	Substantially Equivalent	Icat Systems
K881398	TOURNIQUET	Apr 29, 1988	Substantially Equivalent	Barretta Products, Research and Development, Inc.
K881176	STERILE ESMARCH BANDAGE	Apr 11, 1988	Substantially Equivalent	Spectrum/Hydro-Med Products, Inc.
K875092	DEGANIA SILICONE TOURNIQUET	Jan 07, 1988	Substantially Equivalent	Degania Silicone , Ltd.
K873928	UNIVERSAL TOURNIQUET	Oct 23, 1987	Substantially Equivalent	Dryden Corp.
K872003	KINDERWRAP	Jun 23, 1987	Substantially Equivalent	The Kinder Co.
K864897	DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335	Jan 12, 1987	Substantially Equivalent	Dale Medical Products, Inc.
K853472	FINGER TOURNIQUETTE	Oct 10, 1985	Substantially Equivalent	Joseph B. Marogil
K853537	VELCRO TOURNIQUET	Sep 12, 1985	Substantially Equivalent	Cp Medical
K852277	CATAPRESS TOURNIGUET	Jun 27, 1985	Substantially Equivalent	Boehringer Ingelheim Pharmaceuticals, Inc.
K851482	TOURNIQUET	Apr 29, 1985	Substantially Equivalent	Polymer Technology Corp.
K843056	ELASTIC BANDAGE	Dec 04, 1984	Substantially Equivalent	Sterile Medical Systems
K840489	DISPOSIQUET A DISPOS. TOURNIQUET	Mar 12, 1984	Substantially Equivalent	Med Lab Products
K830467	TOURNIQUET/LATEX TOURNIQUET	Mar 31, 1983	Substantially Equivalent	Primeline Industries, Inc.
K822553	PRESSURE-QUET TOURNIQUET	Sep 17, 1982	Substantially Equivalent	Nutec Med, Inc.
K821700	LATEX PENROSE DRAIN TUBING	Jun 16, 1982	Substantially Equivalent	Abco Dealers, Inc.
K803142	CONPHAR VELCRO TOUNIGUER	Jan 13, 1981	Substantially Equivalent	Conphar, Inc.
K790802	ESSAR TOURNIQUET FOR VENIPUNCTURE	May 01, 1979	Substantially Equivalent	Stewart Research, Inc.
K780594	VELKET TOURNIQUET	Jun 06, 1978	Substantially Equivalent	Abco Dealers, Inc.
K780429	TOURNEQUET, NON-PNEUMATIC	Apr 18, 1978	Substantially Equivalent	Hemox, Inc.