Cleared Special

ReTrace Ureteral Access Sheath

K181811 · Coloplast A/S · Gastroenterology & Urology

Sep 2018

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K181811 is an FDA 510(k) clearance for the ReTrace Ureteral Access Sheath, a Endoscopic Access Overtube, Gastroenterology-urology (Class II — Special Controls, product code FED), submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on September 7, 2018, 63 days after receiving the submission on July 6, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K181811 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 2018
Decision Date	September 07, 2018
Days to Decision	63 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	FED — Endoscopic Access Overtube, Gastroenterology-urology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.