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FDA 510(k)

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)

K-Number: K160754 · 2016-09-09

ApplicantVenclose, Inc.
Decision Date2016-09-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) is a medical device manufactured by Venclose, Inc.. It received FDA 510(k) clearance on 2016-09-09 under approval number K160754. 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 Radiofrequency System (digiRF Generator, EVSRF Catheter)?

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) is a medical device that received FDA 510(k) clearance on 2016-09-09. It is manufactured by Venclose, Inc.. The 510(k) number is K160754.

When was Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) approved by the FDA?

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) received FDA 510(k) clearance on 2016-09-09, under approval number K160754.

What company makes Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)?

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) is manufactured by Venclose, Inc..

What is the FDA product code for Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)?

The FDA product code for Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) is GEI.

Related Clinical Trials

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Other Devices by Venclose, Inc.

K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) K250068Venclose digiRF Generator (VCRFG1)

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Official Source

View on FDA Database →

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

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