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GAX — Tourniquet, Nonpneumatic Class I

FDA Device Classification

FDA product code GAX covers "Tourniquet, Nonpneumatic", a Class I medical device regulated under 21 CFR 878.5900. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
GAX
Device Class
Class I
Regulation Number
878.5900
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K931198icat systemsUNIQUETSeptember 1, 1993
K881398barretta products, research and developmentTOURNIQUETApril 29, 1988
K881176spectrum/hydro-med productsSTERILE ESMARCH BANDAGEApril 11, 1988
K875092degania siliconeDEGANIA SILICONE TOURNIQUETJanuary 7, 1988
K873928drydenUNIVERSAL TOURNIQUETOctober 23, 1987
K872003kinderKINDERWRAPJune 23, 1987
K864897dale medical productsDALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335January 12, 1987
K853472joseph b. marogilFINGER TOURNIQUETTEOctober 10, 1985
K853537cp medicalVELCRO TOURNIQUETSeptember 12, 1985
K852277boehringer ingelheim pharmaceuticalsCATAPRESS TOURNIGUETJune 27, 1985
K851482polymer technologyTOURNIQUETApril 29, 1985
K843056sterile medical systemsELASTIC BANDAGEDecember 4, 1984
K840489med lab productsDISPOSIQUET A DISPOS. TOURNIQUETMarch 12, 1984
K830467primeline industriesTOURNIQUET/LATEX TOURNIQUETMarch 31, 1983
K822553nutec medPRESSURE-QUET TOURNIQUETSeptember 17, 1982
K821700abco dealersLATEX PENROSE DRAIN TUBINGJune 16, 1982
K803142conpharCONPHAR VELCRO TOUNIGUERJanuary 13, 1981
K790802stewart researchESSAR TOURNIQUET FOR VENIPUNCTUREMay 1, 1979
K780594abco dealersVELKET TOURNIQUETJune 6, 1978
K780429hemoxTOURNEQUET, NON-PNEUMATICApril 18, 1978

FDA data resources