510(k) K160754 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)
| Applicant | Venclose, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Sep 9, 2016 |
| Received | Mar 18, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160754
| 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 |
| Nov 13, 2024 | Bard Peripheral Vascular Inc The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.