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FDA 510(k)

Cerynë Intimate Care

K-Number: K250488 · 2025-12-12

ApplicantAnsella Therapeutics
Decision Date2025-12-12
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Cerynë Intimate Care is the device name listed in this FDA 510(k) record. The listed applicant is Ansella Therapeutics. It received FDA 510(k) clearance on 2025-12-12 under 510(k) number K250488. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cerynë Intimate Care?

Cerynë Intimate Care is a medical device that received FDA 510(k) clearance on 2025-12-12. The listed applicant is Ansella Therapeutics. The 510(k) number is K250488.

When did Cerynë Intimate Care receive FDA 510(k) clearance?

Cerynë Intimate Care received FDA 510(k) clearance on 2025-12-12, under 510(k) number K250488.

Who is the listed applicant for Cerynë Intimate Care?

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

What is the FDA product code for Cerynë Intimate Care?

The FDA product code for Cerynë Intimate Care is NUC.

Related Devices (Code: NUC)

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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