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CRF Radiofrequency Ablation System
FDA 510(k)Class II (US FDA 510(k))
510(k) K192715
Identifiers
- 510(k) Number
- K192715 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A comprehensive review of the CRF Radiofrequency Ablation System for its efficacy, safety, and clinical outcomes in treating various medical conditions.
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 | K192715 | Class II | Active |
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Manufacturer
- Manufacturer
- Cambridge Interventional LLC
- FDA Applicant
- Cambridge Interventional, LLC
Sources (1)
- FDA 510(k) K192715 24 fields · synced Jun 20, 2026