FDA 510(k) Application Details - K243821

Device Classification Name	Laparoscope, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K243821
Device Name	Laparoscope, Gynecologic (And Accessories)
Applicant	A.M.I. Agency for Medical Innovations GmbH Im Letten 1 Feldkirch 6800 AT Other 510(k) Applications for this Company
Contact	Anke Ristow Other 510(k) Applications for this Contact
Regulation Number	884.1720   More FDA Info for this Regulation Number
Classification Product Code	HET Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2024
Decision Date	04/25/2025
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