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510(k) K242031

Béa Applicator (BAP-GB-01) by Stepone Fertility Ltd (T/A Béa Fertility) — Product Code HDR

K242031 is an FDA 510(k) premarket notification submitted by Stepone Fertility Ltd (T/A Béa Fertility) for the device "Béa Applicator (BAP-GB-01)". The FDA issued a decision of Substantially Equivalent on April 2, 2025. The device falls under product code HDR (Cap, Cervical), a Class II device regulated under 21 CFR 884.5250.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2025
Date Received
July 11, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cap, Cervical
Device Class
Class II
Regulation Number
884.5250
Review Panel
OB
Submission Type

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  • K993953 — OVES CERVICAL CAP (March 21, 2000)
  • K945131 — IMAGYN INTRAUTERINE INSEMINATION DEVICE (May 15, 1995)
  • K950714 — COOK INSEMINATION CUP (May 11, 1995)
  • K902171 — MINISPACE(TM) IUI CATHETER (October 5, 1990)
  • K902694 — COAXIAL CATHETER SET (August 28, 1990)
  • K896960 — INTRAUTERINE INSEMINATION CATHETERS (June 26, 1990)
  • K900316 — MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES (April 16, 1990)
  • K900308 — SPERM SELECT SYSTEM (April 13, 1990)
  • K900162 — DGH A-SAN PROBE HOLDER (February 16, 1990)

FDA data resources