Venclose, Inc.
San Jose, CA, US
Venclose, Inc. appears in FDA device records in San Jose, CA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Venclose, Inc. between 2016 and 2025. The busiest year on record is 2025, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2021 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252316 | Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) | GEI | Substantially Equivalent | |
| K250068 | Venclose digiRF Generator (VCRFG1) | GEI | Substantially Equivalent | |
| K211806 | Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter | GEI | Substantially Equivalent | |
| K160754 | Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011879048 | 3011879048 | Venclose, Inc. | 2570 N 1st St Fl 2 # 221, San Jose, CA 95131 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain