FDA 510(k)

Béa Applicator (BAP-GB-01)

K-Number: K242031 · 2025-04-02

ApplicantStepone Fertility Ltd (T/A Béa Fertility)

Decision Date2025-04-02

Product CodeHDR

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Béa Applicator (BAP-GB-01) is the device name listed in this FDA 510(k) record. The listed applicant is Stepone Fertility Ltd (T/A Béa Fertility). It received FDA 510(k) clearance on 2025-04-02 under 510(k) number K242031. The device is classified under product code HDR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Béa Applicator (BAP-GB-01)?

Béa Applicator (BAP-GB-01) is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Stepone Fertility Ltd (T/A Béa Fertility). The 510(k) number is K242031.

When did Béa Applicator (BAP-GB-01) receive FDA 510(k) clearance?

Béa Applicator (BAP-GB-01) received FDA 510(k) clearance on 2025-04-02, under 510(k) number K242031.

Who is the listed applicant for Béa Applicator (BAP-GB-01)?

The FDA 510(k) record lists Stepone Fertility Ltd (T/A Béa Fertility) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Béa Applicator (BAP-GB-01)?

The FDA product code for Béa Applicator (BAP-GB-01) is HDR.

Related Devices (Code: HDR)

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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.