Cleared Traditional

K914530 - ICAN GT DRAINAGE BAG
(FDA 510(k) Clearance)

K914530 · Icn Pharmaceuticals, Inc. · Gastroenterology & Urology device
Dec 1991
Decision
68d
Days
Class 2
Risk

K914530 is an FDA 510(k) clearance for the ICAN GT DRAINAGE BAG. This device is classified as a Tube, Levine (Class II - Special Controls, product code FRQ).

Submitted by Icn Pharmaceuticals, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on December 18, 1991, 68 days after receiving the submission on October 11, 1991.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K914530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1991
Decision Date December 18, 1991
Days to Decision 68 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code FRQ — Tube, Levine
Device Class Class II - Special Controls
CFR Regulation 21 CFR 876.5980