Cleared Traditional

K123675 - RE-TRACE URETERAL ACCESS SHEATH

K123675 is the FDA 510(k) clearance for RE-TRACE URETERAL ACCESS SHEATH by Coloplast A/S. It is a Class 2 Gastroenterology & Urology device (product code FED) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K123675 · Coloplast A/S · Gastroenterology & Urology device
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Mar 2013
Decision
91d
Days
Class 2
Risk

K123675 is an FDA 510(k) clearance for the RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL .... 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 March 1, 2013 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Coloplast A/S devices

Submission Details

510(k) Number K123675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2012
Decision Date March 01, 2013
Days to Decision 91 days
Submission Type Traditional
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
39d faster than avg
Panel avg: 130d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 57
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K123675.
Proxis Ureteral Access Sheath
K160861 · C.R. Bard, Inc. · Mar 2016
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
K140523 · Coloplast A/S · Jul 2014
ANAL RECTAL OVERTUBE
K131598 · United States Endoscopy Group, Inc. · Feb 2014
NAVIGATOR HD URETERAL ACCESS SHEATH SET
K122649 · Boston Scientific Corp · Dec 2012
RE-TRACE URETERAL ACCESS SHEATH
K102485 · Coloplast A/S · Oct 2010
ENTEROSCOPY OVERTUBE, MODEL 00712140
K100081 · United States Endoscopy Group, Inc. · Apr 2010