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
K022721Substantially Equivalent

Uropower

Novanta Medical GmbH, Alexandria VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022721 is the FDA 510(k) clearance record for UROPOWER, a class II device, cleared for W.O.M. World of Medicine AG on under FDA product code EXY (Uroflowmeter). FDA records list 41 510(k) clearances for Novanta Medical GmbH, from to . As of , FDA records show no recalls naming K022721.

Clearance record

Decision date
Received
(375 days to decision)
Product code
EXY Uroflowmeter
Regulation
21 CFR 876.1800
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
W.O.M. World of Medicine AG 368 N. Asaph St., Alexandria VA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EXY

Trailing 12 months

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

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