Cleared Traditional

Angled Tip Ureteral Catheter

K181144 · Cook Incorporated · Gastroenterology & Urology
Jun 2018
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K181144 is an FDA 510(k) clearance for the Angled Tip Ureteral Catheter, a Catheter, Urological (Class II — Special Controls, product code KOD), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on June 28, 2018, 58 days after receiving the submission on May 1, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K181144 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2018
Decision Date June 28, 2018
Days to Decision 58 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KOD — Catheter, Urological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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