Cleared Special

K181811 - ReTrace Ureteral Access Sheath

K181811 is the FDA 510(k) clearance for ReTrace Ureteral Access Sheath by Coloplast A/S. It is a Class 2 Gastroenterology & Urology device (product code FED) cleared through the Special 510(k) pathway after a 63-day FDA review.

K181811 · Coloplast A/S · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
63d
Days
Class 2
Risk

K181811 is an FDA 510(k) clearance for the ReTrace Ureteral Access Sheath. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on September 7, 2018 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Coloplast A/S devices

Submission Details

510(k) Number K181811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 130d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FED Endoscopic Access Overtube, Gastroenterology-urology
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FED Endoscopic Access Overtube, Gastroenterology-urology

All 62
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K181811.
Peel-Away Introducer
K182403 · Cook Incorporated · May 2019
Flexible Overtube
K182520 · Sumitomo Bakelite Co., Ltd. · May 2019
Embrella Endoscopic Distal Attachment
K190030 · Micro-Tech (Nanjing) Co., Ltd. · Mar 2019
ORISE Tissue Retractor System
K173400 · Boston Scientific · Feb 2018
Trans-anal Introducer
K171208 · Visionsense, Ltd. · Feb 2018
BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap
K172575 · Baronova, Inc. · Jan 2018