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FDA 510(k)

Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500

K-Number: K222260 · 2023-03-28

Decision Date2023-03-28
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 is the device name listed in this FDA 510(k) record. The listed applicant is Capenergy Medical S.L.. It received FDA 510(k) clearance on 2023-03-28 under 510(k) number K222260. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500?

Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 is a medical device that received FDA 510(k) clearance on 2023-03-28. The listed applicant is Capenergy Medical S.L.. The 510(k) number is K222260.

When did Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 receive FDA 510(k) clearance?

Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 received FDA 510(k) clearance on 2023-03-28, under 510(k) number K222260.

Who is the listed applicant for Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500?

The FDA 510(k) record lists Capenergy Medical S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500?

The FDA product code for Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 is PBX.

Other records listing Capenergy Medical S.L. 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.

Related Devices (Code: PBX)

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.

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.