KCY — Tourniquet, Pneumatic Class I

FDA Device Classification

Classification Details

Product Code
KCY
Device Class
Class I
Regulation Number
878.5910
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K202919mcewen and associates consultingATS 5000 Automatic Tourniquet InstrumentMay 20, 2021
K162365terumobctT-CuffFebruary 16, 2017
K123553zimmerZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEMAugust 9, 2013
K112874dominion medical devicesEZ VEIN INFLATABLE TOURNIQUETOctober 17, 2011
K071140top spinsMRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002June 7, 2007
K050411zimmerZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEMSeptember 2, 2005
K012632medical instruments technologyTOURNIQUET CUFF; PNEUMATIC TOURNIQUETOctober 26, 2001
K955552smith and nephew richardsEXPRESSAIRE TORUNIQUET SYSTEMJanuary 5, 1996
K954201promedicBUONAFEDE PNEUMATIC SLEEVENovember 9, 1995
K954103scandinavian medical jwTOURNI-COMPNovember 1, 1995
K953953deroyal industriesDEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFFSeptember 29, 1995
K952038instrumedCLEAN-CUFFJuly 11, 1995
K940615instrumedACCUTESTMay 19, 1995
K945167dj medicalDJ MEDICAL PNEUMATIC TOURNIQUETFebruary 13, 1995
K942303technadyne scientificTECNADYNE T-CUFFJuly 20, 1994
K933994arthrexARTHREX TOURNIQUET FOR LEG HOLDERMarch 23, 1994
K925033ferguson medicalSTILLE AUTOMATIC TOURNIQUETFebruary 1, 1993
K924273instrumedACCUFLATEJanuary 12, 1993
K910449crantecPRESTITCHMay 29, 1992
K910512instrumedACCUFLATEFebruary 19, 1991