Identifiers
- 510(k) Number
- K955019 FDA 510(k)
- FDA Product Code
- KQS FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.4890 FDA 510(k)
- Regulation Number
- 876.4890 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Urotract I by Dornier MedTech America, Inc. — Class I — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
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 | K955019 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dornier MedTech America, Inc.
Sources (1)
- FDA 510(k) K955019 24 fields · synced Jun 18, 2026