Cleared Traditional

Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)

K242173 · Coloplast Corp. · Gastroenterology & Urology

Nov 2024

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K242173 is an FDA 510(k) clearance for the Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12), a Endoscopic Access Overtube, Gastroenterology-urology (Class II — Special Controls, product code FED), submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on November 12, 2024, 111 days after receiving the submission on July 24, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K242173 FDA.gov
FDA Decision	Cleared 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

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.