510(k) Report

Devices descending from K160754

3 later devices reach Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)Venclose, Inc.20250—
+1K250068Venclose digiRF Generator (VCRFG1)Venclose, Inc.202511
+1K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF…Venclose, Inc.202121