Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)— 510(k) K242173

Name: FDA 510(k) clearance K242173
Creator: U.S. Food and Drug Administration
Published: 2024-11-12

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K242173 for Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12), Substantially Equivalent on 2024-11-12. Applicant: Coloplast Corp.. Device class: 2.

Clearance details

Applicant: Coloplast Corp.
Product code: Code FED
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2024-07-24
Decision date: 2024-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FED

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K260410 — Single Use Ureteral Access Sheath2026-09-11
K261915 — Navigator Flex Ureteral Access Sheath Set2026-08-04
K260965 — CVAC Aspiration System2026-04-13
K260521 — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)2026-04-06
K252572 — Prodeon Urethral Sheath System2025-10-07

More clearances from Coloplast Corp.

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Adverse events under product code FED

product code FED

Death: 10
Total: 10

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.