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FDA 510(k)

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

K-Number: K252316 · 2025-08-19

ApplicantVenclose, Inc.
Decision Date2025-08-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) is the device name listed in this FDA 510(k) record. The listed applicant is Venclose, Inc.. It received FDA 510(k) clearance on 2025-08-19 under 510(k) number K252316. 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 EVSRF Catheter (VC10A256F60, VC10A256F100)?

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) is a medical device that received FDA 510(k) clearance on 2025-08-19. The listed applicant is Venclose, Inc.. The 510(k) number is K252316.

When did Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) receive FDA 510(k) clearance?

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) received FDA 510(k) clearance on 2025-08-19, under 510(k) number K252316.

Who is the listed applicant for Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)?

The FDA 510(k) record lists Venclose, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)?

The FDA product code for Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) is GEI.

Other records listing Venclose, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250068Venclose digiRF Generator (VCRFG1)K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven CatheterK160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)

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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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