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HDR

Cap, Cervical

Product code
HDR
Device name
Cap, Cervical
Device class
Class 2
21 CFR
21 CFR 884.5250
Medical specialty
Obstetrics/Gynecology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
29 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-04-02.

NumberDecision dateApplicantDevice nameSummary
K2420312025-04-02Stepone Fertility Ltd (T/A Béa Fertili…Béa Applicator (BAP-GB-01)PDF

1 summaries are archived here for direct download.

Official FDA classification page: HDR
Classification and pathway per current FDA publications. Data from openFDA (CC0).