FDA 510(k)

Morpheus

K-Number: K210636 · 2022-02-15

Decision Date2022-02-15

Product CodeLRK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Morpheus is the device name listed in this FDA 510(k) record. The listed applicant is S4S UK , Ltd.. It received FDA 510(k) clearance on 2022-02-15 under 510(k) number K210636. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Morpheus?

Morpheus is a medical device that received FDA 510(k) clearance on 2022-02-15. The listed applicant is S4S UK , Ltd.. The 510(k) number is K210636.

When did Morpheus receive FDA 510(k) clearance?

Morpheus received FDA 510(k) clearance on 2022-02-15, under 510(k) number K210636.

Who is the listed applicant for Morpheus?

The FDA 510(k) record lists S4S UK , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Morpheus?

The FDA product code for Morpheus is LRK.

Related Devices (Code: LRK)

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.