Béa Applicator (BAP-GB-01)— 510(k) K242031

Substantially Equivalent

Stepone Fertility Ltd (T/A Béa Fertility)

FDA 510(k) clearance K242031 for Béa Applicator (BAP-GB-01), Substantially Equivalent on 2025-04-02. Applicant: Stepone Fertility Ltd (T/A Béa Fertility).

Clearance details

Applicant: Stepone Fertility Ltd (T/A Béa Fertility)
Product code: Code HDR
Advisory panel: Obstetrics/Gynecology
Date received: 2024-07-11
Decision date: 2025-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

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Data sourced from openFDA. This site is unofficial and independent of the FDA.