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Retrace Ureteral Access Sheath - ASXL10

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242173

by Coloplast Corp.

Identifiers

510(k) Number
K242173 FDA 510(k)
FDA Product Code
FED FDA 510(k)
Models / Variants
ASXL10 FDA 510(k)
ASXL12 FDA 510(k)
ACXL10 FDA 510(k)
ACXL12 FDA 510(k)
AXXL10 FDA 510(k)
AXXL12 FDA 510(k)
ALXL10 FDA 510(k)
ALXL12 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Retrace Ureteral Access Sheath is an endoscopic access overtube designed for use in gastroenterology and urology procedures. It is a single-use device intended to facilitate access to the urinary tract during endoscopic interventions.

The device is supplied in multiple size variants including ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, and ALXL12, with corresponding French sizes and lengths as indicated in the model designations. It received FDA 510(k) clearance (K242173) on November 12, 2024, and is classified as a Class II medical device under regulation number 876.1500.

Frequently asked questions

What is the Retrace Ureteral Access Sheath used for?

The Retrace Ureteral Access Sheath is an endoscopic access overtube designed to facilitate access to the urinary tract during endoscopic interventions in gastroenterology and urology procedures, as it provides a pathway for instruments while protecting the ureteral mucosa.

How is the Retrace Ureteral Access Sheath supplied and is it reusable?

The device is supplied as a single-use product in multiple size variants (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) and is intended for one-time use only to prevent cross-contamination and ensure optimal performance.

What sizes and models are available for the Retrace Ureteral Access Sheath?

The Retrace Ureteral Access Sheath is available in eight size variants: ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, and ALXL12, each corresponding to specific French sizes and lengths as indicated by the model designations.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ReTrace® Access Sheath - Coloplast, PDF Ready, Set, ReTrace. - Coloplast -, Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10 ..., ReTrace - Coloplast

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Coloplast Corp.

Sources (1)

  • FDA 510(k) K242173 24 fields · synced Oct 6, 2026