510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K933994Substantially Equivalent

Arthrex Tourniquet for Leg Holder

Arthrex GmbH, Naples FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933994 is the FDA 510(k) clearance record for ARTHREX TOURNIQUET FOR LEG HOLDER, a class I device, cleared for Arthrex, Inc. on under FDA product code KCY (Tourniquet, Pneumatic). FDA records list 352 510(k) clearances for Arthrex, Inc., from to . As of , FDA records show no recalls naming K933994.

Clearance record

Decision date
Received
(218 days to decision)
Product code
KCY Tourniquet, Pneumatic
Regulation
21 CFR 878.5910
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Arthrex, Inc. 3050 N. Horseshoe Dr., Naples FL
510(k) summary
Statement
Third party review
No

Clearances, product code KCY

Trailing 12 months

FDA records hold no clearances under product code KCY in the trailing twelve months.

FDA records show no clearances under product code KCY in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KCY, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260