Coloplast Corp. · Class II · Cleared Nov 12, 2024
| K-number | K242173 |
| Device name | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) |
| Applicant | Coloplast Corp. |
| Product code | FED |
| Device class | Class II |
| Decision date | Nov 12, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
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