Venclose, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)August 19, 2025
K250068Venclose digiRF Generator (VCRFG1)February 4, 2025
K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, VenAugust 3, 2021
K160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)September 9, 2016