510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853472Substantially Equivalent

Finger Tourniquette

Joseph B. Marogil, Grand Rapids MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853472 is the FDA 510(k) clearance record for FINGER TOURNIQUETTE, a class I device, cleared for Joseph B. Marogil on under FDA product code GAX (Tourniquet, Nonpneumatic). FDA records list one 510(k) clearance for Joseph B. Marogil. As of , FDA records show one recall naming K853472.

Clearance record

Decision date
Received
(51 days to decision)
Product code
GAX Tourniquet, Nonpneumatic
Regulation
21 CFR 878.5900
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Joseph B. Marogil Towers Medical Bldg. 515, Grand Rapids MI
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