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FDA 510(k)

Venclose digiRF Generator (VCRFG1)

K-Number: K250068 · 2025-02-04

ApplicantVenclose, Inc.
Decision Date2025-02-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Venclose digiRF Generator (VCRFG1) is a medical device manufactured by Venclose, Inc.. It received FDA 510(k) clearance on 2025-02-04 under approval number K250068. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Venclose digiRF Generator (VCRFG1)?

Venclose digiRF Generator (VCRFG1) is a medical device that received FDA 510(k) clearance on 2025-02-04. It is manufactured by Venclose, Inc.. The 510(k) number is K250068.

When was Venclose digiRF Generator (VCRFG1) approved by the FDA?

Venclose digiRF Generator (VCRFG1) received FDA 510(k) clearance on 2025-02-04, under approval number K250068.

What company makes Venclose digiRF Generator (VCRFG1)?

Venclose digiRF Generator (VCRFG1) is manufactured by Venclose, Inc..

What is the FDA product code for Venclose digiRF Generator (VCRFG1)?

The FDA product code for Venclose digiRF Generator (VCRFG1) is GEI.

Other Devices by Venclose, Inc.

K160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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