510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831384Substantially Equivalent

Coaxial Balloon Urethral Dilator

Thomas J. Fogarty, M.D., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831384 is the FDA 510(k) clearance record for COAXIAL BALLOON URETHRAL DILATOR, a class II device, cleared for Thomas J. Fogarty, M.D. on under FDA product code FAH (Dilator, Urethral, Mechanical). FDA records list 6 510(k) clearances for Thomas J. Fogarty, M.D., from to . As of , FDA records show no recalls naming K831384.

Clearance record

Decision date
Received
(89 days to decision)
Product code
FAH Dilator, Urethral, Mechanical
Regulation
21 CFR 876.5520
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Thomas J. Fogarty, M.D. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FAH

Trailing 12 months

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

FDA records show no clearances under product code FAH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FAH, 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