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510(k) K910512

ACCUFLATE by Instrumed, Inc. — Product Code KCY

K910512 is an FDA 510(k) premarket notification submitted by Instrumed, Inc. for the device "ACCUFLATE". The FDA issued a decision of Substantially Equivalent on February 19, 1991. The device falls under product code KCY (Tourniquet, Pneumatic), a Class I device regulated under 21 CFR 878.5910. Instrumed, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1991
Date Received
February 5, 1991
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 Instrumed, Inc.

  • K952038 — CLEAN-CUFF (July 11, 1995)
  • K940615 — ACCUTEST (May 19, 1995)
  • K924273 — ACCUFLATE (January 12, 1993)
  • K924373 — ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP (November 25, 1992)
  • K890014 — DISPOSABLE COLOR-CUFFS (January 24, 1989)
  • K860617 — POLYPET (March 3, 1986)

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)
  • K012632 — TOURNIQUET CUFF; PNEUMATIC TOURNIQUET (October 26, 2001)
  • K955552 — EXPRESSAIRE TORUNIQUET SYSTEM (January 5, 1996)
  • K954201 — BUONAFEDE PNEUMATIC SLEEVE (November 9, 1995)
  • K954103 — TOURNI-COMP (November 1, 1995)

FDA data resources