Béa Applicator (BAP-GB-01)
K-Number: K242031 · 2025-04-02
Decision Date2025-04-02
Product CodeHDR
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Béa Applicator (BAP-GB-01) is a medical device manufactured by Stepone Fertility Ltd (T/A Béa Fertility). It received FDA 510(k) clearance on 2025-04-02 under approval 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. It is manufactured by Stepone Fertility Ltd (T/A Béa Fertility). The 510(k) number is K242031.
When was Béa Applicator (BAP-GB-01) approved by the FDA?
Béa Applicator (BAP-GB-01) received FDA 510(k) clearance on 2025-04-02, under approval number K242031.
What company makes Béa Applicator (BAP-GB-01)?
Béa Applicator (BAP-GB-01) is manufactured by Stepone Fertility Ltd (T/A Béa Fertility).
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)
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.