FDA 510(k) Applications for Medical Device Product Code "HDR"
(Cap, Cervical)

FDA 510(k) Number Applicant Device Name Decision Date
K222969 Rosesta Medical BV FERTI-LILY Conception Cup 06/23/2023
K242031 StepOne Fertility Ltd (t/a BΘa Fertility) BΘa Applicator (BAP-GB-01) 04/02/2025
K993953 VEOS LTD. OVES CERVICAL CAP 03/21/2000


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