Cleared Traditional

K934142 - URINARY DRAINAGE BAG (FDA 510(k) Clearance)

K934142 · Key Medical Services, Inc. · Gastroenterology & Urology device

May 1994

Decision

265d

Days

Class 2

Risk

K934142 is an FDA 510(k) clearance for the URINARY DRAINAGE BAG. This device is classified as a Urinometer, Mechanical (Class II - Special Controls, product code EXR).

Submitted by Key Medical Services, Inc. (Chicago, US). The FDA issued a Cleared decision on May 17, 1994, 265 days after receiving the submission on August 25, 1993.

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

Submission Details

510(k) Number	K934142 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 25, 1993
Decision Date	May 17, 1994
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement