Manufacturer
Venclose, Inc.Venclose digiRF Generator (VCRFG1)
Country / Region:United States (US)Submission type:Special
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Device details
FDA 510(k) registration fields
- K number
- K250068
- Device name
- Venclose digiRF Generator (VCRFG1)
- Company
- Venclose, Inc.
- Country / Region
- United States(US)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-01-10
- Decision date
- 2025-02-04
- Submission type
- Special
- Technology type
- RF Generator(AI inferred)
- Clinical applications
- SurgeryOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The Venclose System (Venclose digiRF Generator with EVSRF Catheter) is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux. The Venclose Maven System (digiRF Generator and Maven Catheter) is intended for endovascular coagulation of blood vessels in patients with perforator and tributary vein reflux.
Intended Use
The Venclose System (Venclose digiRF Generator with EVSRF Catheter) is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux. The Venclose Maven System (digiRF Generator and Maven Catheter) is intended for endovascular coagulation of blood vessels in patients with perforator and tributary vein reflux.
Device Description
The Venclose™ digiRF Generator is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter to be used with the generator (time, temperature, etc.), which is connected via a triaxial catheter connector port. The Venclose™ digiRF Generator is intended to be used with Venclose™ RF Catheter(s) (either the Venclose™ EVSRF Catheter or the Venclose™ Maven Catheter) as a system. The Venclose™ RF System uses resistive radiofrequency ablation via energy delivery to heat the wall of an incompetent vein with temperature-controlled RF energy to cause irreversible luminal occlusion, followed by fibrosis and ultimately resorption of the vein.
Summary parsed at:2026-06-20 17:55:10 UTC
Predicate devices
2Cited as predicate
1Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)
1 submission cite K250068 as a predicate