510(k) K250068 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Venclose digiRF Generator (VCRFG1)
| Applicant | Venclose, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Feb 4, 2025 |
| Received | Jan 10, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2025 | Bard Peripheral Vascular Inc Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sop Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.