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

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K252316

Identifiers

510(k) Number: K252316 FDA 510(k)
FDA Product Code: GEI FDA 510(k)
Models / Variants: Venclose digiRF Generator (VCRFG1) FDA 510(k)EUDAMED
Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) FDA 510(k)EUDAMED

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4400 FDA 510(k)
Regulation Number: 878.4400 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Venclose System comprises a digiRF Generator (VCRFG1) and EVSRF Catheter (VC10A256F60, VC10A256F100), designed for endovascular coagulation of blood vessels. This system delivers radiofrequency (RF) energy to occlude superficial veins, aiding in the treatment of venous conditions. The catheters feature heating elements of 10 cm and 2.5 cm lengths, enabling targeted thermal ablation. The device operates within a controlled power range to ensure precise coagulation while minimizing tissue damage.

The Venclose digiRF Generator powers the EVSRF Catheter, delivering RF energy in a time-dependent cycle—starting at 4.8 W/cm (±20%) and reducing to 2.6 W/cm over 20 seconds per treatment cycle. The system is single-use, intended for sterile use in clinical settings such as outpatient clinics or surgical suites. Both components are regulated under FDA 510(k) clearance (K252316) and MDD compliance, with the generator and catheters supplied as a coordinated kit for endovascular procedures. No MRI safety information is specified.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter ..., PDF digiRF User Manual - Venclose, PDF EVSRF™ Instructions for Use - Venclose, Venclose digiRF Generator (VCRFG1); Venclose EVSRF… - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K252316	Class II	Active

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Manufacturer

Manufacturer: Venclose Inc
FDA Applicant: Venclose, Inc.

Sources (2)

FDA 510(k) K252316 24 fields · synced Sep 20, 2026
EUDAMED 1 fields · synced May 19, 2026