Cleared Traditional

K922476 - URO-PRO 2000
(FDA 510(k) Clearance)

K922476 · Fiberoptic Sensor Technlogies, Inc. · Gastroenterology & Urology

Jul 1993

Decision

420d

Days

Class 2

Risk

K922476 is an FDA 510(k) clearance for the URO-PRO 2000. This device is classified as a Cystometric Gas (carbon-dioxide) On Hydraulic Device (Class II — Special Controls, product code FAP).

Submitted by Fiberoptic Sensor Technlogies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on July 20, 1993, 420 days after receiving the submission on May 26, 1992.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1620.

Submission Details

510(k) Number	K922476 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 26, 1992
Decision Date	July 20, 1993
Days to Decision	420 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement