FDA 510(k) Application Details - K223300

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K223300
Device Name	Instrument, Biopsy
Applicant	GEOTEK Medikal Ltd sti Ivedik OSB, Agac Metal Sitesi 1436 Sk. No: 12. Ankara 06378 TR Other 510(k) Applications for this Company
Contact	Latif Iba Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	KNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/27/2022
Decision Date	04/21/2023
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