510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K881398Substantially Equivalent

Tourniquet

Barretta Products, Research and Development, Inc., Mobile AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881398 is the FDA 510(k) clearance record for TOURNIQUET, a class I device, cleared for Barretta Products, Research and Development, Inc. on under FDA product code GAX (Tourniquet, Nonpneumatic). FDA records list one 510(k) clearance for Barretta Products, Research and Development, Inc. As of , FDA records show no recalls naming K881398.

Clearance record

Decision date
Received
(25 days to decision)
Product code
GAX Tourniquet, Nonpneumatic
Regulation
21 CFR 878.5900
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Barretta Products, Research and Development, Inc. 130 Durhu Dr., Dept. D, Mobile AL
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