FDA 510(k) Application Details - K233700

Device Classification Name	Ureteroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K233700
Device Name	Ureteroscope And Accessories, Flexible/Rigid
Applicant	Elmed Elektronik ve Medikal Sanayi ve Ticaret Anonim Sirketi Ostim Teknoloji Gelistirme B÷lgesi Ostim OSB mahallesi Ankara 06374 TR Other 510(k) Applications for this Company
Contact	Ahmet Sinan Kabakci Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FGB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/2023
Decision Date	08/16/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review