Cleared Special

RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM

K140523 · Coloplast A/S · Gastroenterology & Urology

Jul 2014

Decision

142d

Days

Class 2

Risk

About This 510(k) Submission

K140523 is an FDA 510(k) clearance for the RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM, 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 July 24, 2014, 142 days after receiving the submission on March 4, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K140523 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 2014
Decision Date	July 24, 2014
Days to Decision	142 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.