Cleared Traditional

Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter

K182695 · Cook Incorporated · Gastroenterology & Urology
Jun 2019
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K182695 is an FDA 510(k) clearance for the Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter, a Catheter, Ureteral, Gastro-urology (Class II — Special Controls, product code EYB), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on June 17, 2019, 263 days after receiving the submission on September 27, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K182695 FDA.gov
FDA Decision Cleared SESK
Date Received September 27, 2018
Decision Date June 17, 2019
Days to Decision 263 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code EYB — Catheter, Ureteral, Gastro-urology
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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