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ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone dou…
FDA 510(k)Class II (US FDA 510(k))
510(k) K213185
Identifiers
- 510(k) Number
- K213185 FDA 510(k)
- FDA Product Code
- FAD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.4620 FDA 510(k)
- Regulation Number
- 876.4620 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESK Substantially Equivalent — Kit FDA 510(k)
ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone dou… by Coloplast Corp. — Class II — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213185 | Class II | Active |
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Manufacturer
- Manufacturer
- Coloplast Corp.
Sources (1)
- FDA 510(k) K213185 24 fields · synced Jun 19, 2026