510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900781Substantially Equivalent

Working Channel Valve

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

K900781 is the FDA 510(k) clearance record for WORKING CHANNEL VALVE, a class I device, cleared for Applied Urology, Inc. on under FDA product code FFY (Adaptor, Bulbs, Miscellaneous, For Endoscope). FDA records list 13 510(k) clearances for Applied Urology, Inc., from to . As of , FDA records show no recalls naming K900781.

Clearance record

Decision date
Received
(64 days to decision)
Product code
FFY Adaptor, Bulbs, Miscellaneous, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Applied Urology, Inc. 26051 Merit Cir., Launa Hills CA
Third party review
No

Clearances, product code FFY

Trailing 12 months

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

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