FDA 510(k) Application Details - K243296

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K243296
Device Name	Instrument, Biopsy
Applicant	Carbon (Shenzhen) Medical Device Co., Ltd. Roomá203,áBuildingáB,á5#áSkywortháInnovationáVally,áNo.á1 TangtouááRoad,áTangtouáCommunity,áShiyanáStreet,áBao'anáDist Shenzhen 518102 CN Other 510(k) Applications for this Company
Contact	Min Ye 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	10/18/2024
Decision Date	07/11/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review