Home / 510(k) Clearances / K012632

510(k) K012632

TOURNIQUET CUFF; PNEUMATIC TOURNIQUET by Medical Instruments Technology, Inc. — Product Code KCY

K012632 is an FDA 510(k) premarket notification submitted by Medical Instruments Technology, Inc. for the device "TOURNIQUET CUFF; PNEUMATIC TOURNIQUET". The FDA issued a decision of Substantially Equivalent on October 26, 2001. The device falls under product code KCY (Tourniquet, Pneumatic), a Class I device regulated under 21 CFR 878.5910. Medical Instruments Technology, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2001
Date Received
August 13, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tourniquet, Pneumatic
Device Class
Class I
Regulation Number
878.5910
Review Panel
SU
Submission Type

Other clearances by Medical Instruments Technology, Inc.

  • K012614 — KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; A (May 1, 2002)
  • K012640 — ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS (February 28, 2002)
  • K012624 — REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMI (November 8, 2001)
  • K884611 — THE ORTHORANGER II ELECTRONIC GONIOMETER (January 31, 1989)

Other clearances for product code KCY

  • K202919 — ATS 5000 Automatic Tourniquet Instrument (May 20, 2021)
  • K162365 — T-Cuff (February 16, 2017)
  • K123553 — ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM (August 9, 2013)
  • K112874 — EZ VEIN INFLATABLE TOURNIQUET (October 17, 2011)
  • K071140 — MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 (June 7, 2007)
  • K050411 — ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM (September 2, 2005)
  • K955552 — EXPRESSAIRE TORUNIQUET SYSTEM (January 5, 1996)
  • K954201 — BUONAFEDE PNEUMATIC SLEEVE (November 9, 1995)
  • K954103 — TOURNI-COMP (November 1, 1995)
  • K953953 — DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF (September 29, 1995)

FDA data resources