Venclose digiRF Generator VCRFG1
FDA 510(k)Class II (US FDA 510(k))
by Venclose Inc
Identifiers
- 510(k) Number
- K250068 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
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 digiRF Generator VCRFG1 is a multi-voltage energy delivery system designed for radiofrequency ablation. It features touch screen control and automatically sets non-adjustable treatment parameters for use with the RF catheter.
This device is supplied as a generator with a power cord and is intended for use with the Venclose RF ablation catheter. It has received FDA 510k clearance under K250068.
Frequently asked questions
What is the primary function of the Venclose digiRF Generator VCRFG1?
The VCRFG1 is a multi-voltage energy delivery system specifically engineered for radiofrequency ablation procedures. It utilizes a touch screen interface to manage energy delivery and automatically sets non-adjustable treatment parameters to ensure consistent operation when paired with the Venclose RF ablation catheter.
What components are included with the generator upon supply?
The device is supplied as a complete generator unit accompanied by a power cord. It is designed to function as a system specifically with the Venclose RF ablation catheter, which is required to perform the intended ablation procedure.
What is the regulatory status of the Venclose digiRF Generator?
The Venclose digiRF Generator VCRFG1 has received FDA 510k clearance under K250068. This indicates that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.
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: PDF digiRF User Manual - Venclose, PDF digiRF User Manual - venclose.com, MAUDE Adverse Event Report: Venclose, Inc. Venclose System digiRF ..., Class 2 Device Recall Venclose digiRF Generators (VCRFG1), Venclose™ RF Ablation Catheter - BD
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250068 | Class II | Active |
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Manufacturer
- Manufacturer
- Venclose Inc
- FDA Applicant
- Venclose, Inc.
Sources (1)
- FDA 510(k) K250068 24 fields · synced Sep 26, 2026