Béa Applicator (BAP-GB-01)— 510(k) K242031
Substantially EquivalentStepone 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). Device class: 2.
Clearance details
- Applicant
- Stepone Fertility Ltd (T/A Béa Fertility)
- Product code
- Code HDR
- Device class
- Class 2
- Regulation
- 21 CFR 884.5250
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- London, GB
Recent devices under product code HDR
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