Cleared Special

SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM

K070939 · Coloplast Manufacturing Us, LLC · Gastroenterology & Urology
Jun 2007
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K070939 is an FDA 510(k) clearance for the SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM, a Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (Class II — Special Controls, product code FCM), submitted by Coloplast Manufacturing Us, LLC (Minneapolis, US). The FDA issued a Cleared decision on June 1, 2007, 58 days after receiving the submission on April 4, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K070939 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2007
Decision Date June 01, 2007
Days to Decision 58 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FCM — Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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