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FDA 510(k)

Morpheus® Moldable; Agilon® Moldable

K-Number: K240621 · 2024-04-30

ApplicantBiogennix, LLC
Decision Date2024-04-30
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Morpheus® Moldable; Agilon® Moldable is the device name listed in this FDA 510(k) record. The listed applicant is Biogennix, LLC. It received FDA 510(k) clearance on 2024-04-30 under 510(k) number K240621. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Morpheus® Moldable; Agilon® Moldable?

Morpheus® Moldable; Agilon® Moldable is a medical device that received FDA 510(k) clearance on 2024-04-30. The listed applicant is Biogennix, LLC. The 510(k) number is K240621.

When did Morpheus® Moldable; Agilon® Moldable receive FDA 510(k) clearance?

Morpheus® Moldable; Agilon® Moldable received FDA 510(k) clearance on 2024-04-30, under 510(k) number K240621.

Who is the listed applicant for Morpheus® Moldable; Agilon® Moldable?

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

What is the FDA product code for Morpheus® Moldable; Agilon® Moldable?

The FDA product code for Morpheus® Moldable; Agilon® Moldable is MQV.

Other records listing Biogennix, LLC as applicant

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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.

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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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