510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890284Substantially Equivalent

Urodec 500

Ferguson Medical, Chico CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890284 is the FDA 510(k) clearance record for URODEC 500, a class II device, cleared for Ferguson Medical on under FDA product code FES (Recorder, External, Pressure, Amplifier & Transducer). FDA records list 57 510(k) clearances for Ferguson Medical, from to . As of , FDA records show no recalls naming K890284.

Clearance record

Decision date
Received
(131 days to decision)
Product code
FES Recorder, External, Pressure, Amplifier & Transducer
Regulation
21 CFR 876.1725
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Ferguson Medical 3407 Bay Ave., Chico CA
Third party review
No

Clearances, product code FES

Trailing 12 months

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

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