Cleared Traditional

SELF CATH CATHETER

K100878 · Coloplast Manufacturing Us, LLC · Gastroenterology & Urology
May 2010
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K100878 is an FDA 510(k) clearance for the SELF CATH CATHETER, a Catheter, Straight (Class II — Special Controls, product code EZD), submitted by Coloplast Manufacturing Us, LLC (Minneapolis, US). The FDA issued a Cleared decision on May 26, 2010, 57 days after receiving the submission on March 30, 2010. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K100878 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2010
Decision Date May 26, 2010
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code EZD — Catheter, Straight
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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