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RenaFlex Single-use Flexible Ureteroscope - Video System Center for Single-use Endoscopes (CV-S1)
FDA 510(k)Class II (US FDA 510(k))
510(k) K233275
Identifiers
- 510(k) Number
- K233275 FDA 510(k)
- FDA Product Code
- FGB FDA 510(k)
- Models / Variants
- Video System Center for Single-use Endoscopes (CV-S1) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
RenaFlex Single-use Flexible Ureteroscope - Video System Center for Single-use Endoscopes (CV-S1) by Gyrus Acmi, Inc. — Class II — FDA_510K — listed in FDA…
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 | K233275 | Class II | Active |
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Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA 510(k) K233275 24 fields · synced Jun 18, 2026