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FDA 510(k)

Capenergy C Equipments RF C200 and C400 Drakarian

K-Number: K253480 · 2026-07-10

Decision Date2026-07-10
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Capenergy C Equipments RF C200 and C400 Drakarian 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 2026-07-10 under 510(k) number K253480. 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 Equipments RF C200 and C400 Drakarian?

Capenergy C Equipments RF C200 and C400 Drakarian is a medical device that received FDA 510(k) clearance on 2026-07-10. The listed applicant is Capenergy Medical S.L.. The 510(k) number is K253480.

When did Capenergy C Equipments RF C200 and C400 Drakarian receive FDA 510(k) clearance?

Capenergy C Equipments RF C200 and C400 Drakarian received FDA 510(k) clearance on 2026-07-10, under 510(k) number K253480.

Who is the listed applicant for Capenergy C Equipments RF C200 and C400 Drakarian?

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 Equipments RF C200 and C400 Drakarian?

The FDA product code for Capenergy C Equipments RF C200 and C400 Drakarian 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.