# Venclose, Inc.

- Location (FDA's records): San Jose, CA
- FDA decisions: 4 (2016–2025): 4 510(k) clearances
- Product codes: GEI (4)
- 510(k) review time since 2016: median 39 days, against 113 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 8 (5 its own); citations of its devices by later devices: 5 (5 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Vnus Medical Technologies, Inc.: 3 (https://510kreport.com/company/vnus-medical-technologies)

## Its most-cited devices
- K160754: Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) (2016), cited by 3
- K250068: Venclose digiRF Generator (VCRFG1) (2025), cited by 1
- K211806: Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter (2021), cited by 1

## Recent decisions
- K252316: Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) (Aug 19, 2025)
- K250068: Venclose digiRF Generator (VCRFG1) (Feb 4, 2025)
- K211806: Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter (Aug 3, 2021)
- K160754: Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) (Sep 9, 2016)

Source page: https://510kreport.com/company/venclose