Class Class II
Venclose digiRF Generator (VCRFG1) (K250068)
Description
Venclose digiRF Generator (VCRFG1) by Venclose, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250068
Clearance Date2025-02-04
Clearance TypeSpecial
Product CodeGEI
Regulation Number878.4400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250068
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Venclose digiRF Generator (VCRFG1) (K250068) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211806 | Venclose digiRF Generator with Maven Catheter, Venclose Mav... | Venclose, Inc. | 2021 |
| K160754 | Venclose Radiofrequency System (digiRF Generator, EVSRF Cat... | Venclose, Inc. | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K252316 | Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter... | Venclose, Inc. | 2025 |
Trace the full predicate network for K250068
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.