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FDA 510(k)

Cocoon Solo (DX-7020s)

K-Number: K250687 · 2025-10-24

ApplicantDexcowin Global, Inc.
Decision Date2025-10-24
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Cocoon Solo (DX-7020s) is a medical device manufactured by Dexcowin Global, Inc.. It received FDA 510(k) clearance on 2025-10-24 under approval number K250687. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cocoon Solo (DX-7020s)?

Cocoon Solo (DX-7020s) is a medical device that received FDA 510(k) clearance on 2025-10-24. It is manufactured by Dexcowin Global, Inc.. The 510(k) number is K250687.

When was Cocoon Solo (DX-7020s) approved by the FDA?

Cocoon Solo (DX-7020s) received FDA 510(k) clearance on 2025-10-24, under approval number K250687.

What company makes Cocoon Solo (DX-7020s)?

Cocoon Solo (DX-7020s) is manufactured by Dexcowin Global, Inc..

What is the FDA product code for Cocoon Solo (DX-7020s)?

The FDA product code for Cocoon Solo (DX-7020s) is MUH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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