FDA 510(k) Application Details - K242031

Device Classification Name	Cap, Cervical   More FDA Info for this Device
510(K) Number	K242031
Device Name	Cap, Cervical
Applicant	StepOne Fertility Ltd (t/a BΘa Fertility) 71-75 Shelton Street Covent Garden London WC2H 9JQ GB Other 510(k) Applications for this Company
Contact	Tom Littleford Other 510(k) Applications for this Contact
Regulation Number	884.5250   More FDA Info for this Regulation Number
Classification Product Code	HDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2024
Decision Date	04/02/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review