K242173
- 510(k) number
- K242173
- Device name
- Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)
- Applicant
- Coloplast Corp. MN · US
- Product code
- FED — Endoscopic Access Overtube, Gastroenterology-Urology
- Decision date
- 2024-11-12
- Date received
- 2024-07-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242173.pdf
Official FDA record: K242173
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.