Last synced on 14 November 2025 at 11:06 pm

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)

Page Type
Cleared 510(K)
510(k) Number
K252316
510(k) Type
Special
Applicant
Venclose, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/19/2025
Days to Decision
25 days
Submission Type
Summary

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)

Page Type
Cleared 510(K)
510(k) Number
K252316
510(k) Type
Special
Applicant
Venclose, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/19/2025
Days to Decision
25 days
Submission Type
Summary