Cleared Abbreviated

EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER

K041416 · Deroyal · Gastroenterology & Urology

Jul 2004

Decision

36d

Days

Class 2

Risk

About This 510(k) Submission

K041416 is an FDA 510(k) clearance for the EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER, a Catheter, Upper Urinary Tract (Class II — Special Controls, product code EYC), submitted by Deroyal (Knoxville, US). The FDA issued a Cleared decision on July 2, 2004, 36 days after receiving the submission on May 27, 2004. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number	K041416 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2004
Decision Date	July 02, 2004
Days to Decision	36 days
Submission Type	Abbreviated
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement