FDA 510(k) Application Details - K240227

Device Classification Name	Cystoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K240227
Device Name	Cystoscope And Accessories, Flexible/Rigid
Applicant	LiNA Medical Aps Formervangen 5 Glostrup DK-2600 DK Other 510(k) Applications for this Company
Contact	Barczak Katarzyna Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FAJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/26/2024
Decision Date	08/22/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review