Cleared Traditional

K022721 - UROPOWER
(FDA 510(k) Clearance)

K022721 · W.O.M. World of Medicine AG · Gastroenterology & Urology device

Aug 2003

Decision

375d

Days

Class 2

Risk

K022721 is an FDA 510(k) clearance for the UROPOWER. This device is classified as a Uroflowmeter (Class II - Special Controls, product code EXY).

Submitted by W.O.M. World of Medicine AG (Alexandria, US). The FDA issued a Cleared decision on August 26, 2003, 375 days after receiving the submission on August 16, 2002.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1800.

Submission Details

510(k) Number	K022721 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 16, 2002
Decision Date	August 26, 2003
Days to Decision	375 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF