510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852277Substantially Equivalent

Catapress Tourniguet

Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852277 is the FDA 510(k) clearance record for CATAPRESS TOURNIGUET, a class I device, cleared for Boehringer Ingelheim Pharmaceuticals, Inc. on under FDA product code GAX (Tourniquet, Nonpneumatic). FDA records list 2 510(k) clearances for Boehringer Ingelheim Pharmaceuticals, Inc., from to . As of , FDA records show no recalls naming K852277.

Clearance record

Decision date
Received
(29 days to decision)
Product code
GAX Tourniquet, Nonpneumatic
Regulation
21 CFR 878.5900
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Boehringer Ingelheim Pharmaceuticals, Inc. 90 E. Ridge, Ridgefield CT
Third party review
No

Clearances, product code GAX

Trailing 12 months

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

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