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
K903994Substantially Equivalent

Ureteropyelogram Cath for Retrograde Dye Injection

Applied Urology, Inc., Launa Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903994 is the FDA 510(k) clearance record for URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION, a class II device, cleared for Applied Urology, Inc. on under FDA product code FGF (Catheter, Ureteral Disposable (X-Ray)). FDA records list 13 510(k) clearances for Applied Urology, Inc., from to . As of , FDA records show no recalls naming K903994.

Clearance record

Decision date
Received
(51 days to decision)
Product code
FGF Catheter, Ureteral Disposable (X-Ray)
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Applied Urology, Inc. 26051 Merit Cir., Launa Hills CA
Third party review
No

Clearances, product code FGF

Trailing 12 months

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

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