Cleared Traditional

K242173 - Retrace Ureteral Access Sheath (ASXL10

K242173 is the FDA 510(k) clearance for Retrace Ureteral Access Sheath (ASXL10 by Coloplast Corp.. It is a Class 2 Gastroenterology & Urology device (product code FED) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K242173 · Coloplast Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
111d
Days
Class 2
Risk

K242173 is an FDA 510(k) clearance for the Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL1.... Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on November 12, 2024 after a review of 111 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 Corp. devices

Submission Details

510(k) Number K242173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2024
Decision Date November 12, 2024
Days to Decision 111 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
19d faster than avg
Panel avg: 130d · This submission: 111d
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 62
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K242173.
Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210)
K250517 · Boston Scientific Corporation · Mar 2025
Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250
K243820 · Dornier Medtech America · Jan 2025
Ureteral Access Sheath
K243025 · Seplou (Zhuhai) Co., Ltd. · Jan 2025
Over-tube (TR-1108A)
K243091 · Fujifilm Corporation · Nov 2024
Single-use Ureteral Access Sheath
K240167 · Hunan Vathin Medical Instrument Co., Ltd. · Oct 2024
Disposable Ureteral Guide Sheath
K241181 · Dongguan Zsr Biomedical Technology Company Limited · Aug 2024