Cleared Traditional

K881217 - GENT-L-KARE STERILE URINARY LEG BAG
(FDA 510(k) Clearance)

K881217 · Geneva Laboratories, Inc. · Gastroenterology & Urology

Jul 1988

Decision

129d

Days

Class 2

Risk

K881217 is an FDA 510(k) clearance for the GENT-L-KARE STERILE URINARY LEG BAG. This device is classified as a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II — Special Controls, product code KNX).

Submitted by Geneva Laboratories, Inc. (Elkhorn, US). The FDA issued a Cleared decision on July 29, 1988, 129 days after receiving the submission on March 22, 1988.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.

Submission Details

510(k) Number	K881217 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 1988
Decision Date	July 29, 1988
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—