K252316
- 510(k) number
- K252316
- Device name
- Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)
- Applicant
- Venclose, Inc. CA · US
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2025-08-19
- Date received
- 2025-07-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K252316.pdf
Official FDA record: K252316
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.