Cleared Traditional

K973070 - CONVEEN EASICATH SET (FDA 510(k) Clearance)

K973070 · Coloplast Corp. · Gastroenterology & Urology device

Nov 1997

Decision

80d

Days

Class 2

Risk

K973070 is an FDA 510(k) clearance for the CONVEEN EASICATH SET. This device is classified as a Catheter, Straight (Class II - Special Controls, product code EZD).

Submitted by Coloplast Corp. (Marietta, US). The FDA issued a Cleared decision on November 6, 1997, 80 days after receiving the submission on August 18, 1997.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number	K973070 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 18, 1997
Decision Date	November 06, 1997
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF