FDA 510(k) Application Details - K231267

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K231267
Device Name	Kit, Needle, Biopsy
Applicant	Finemedix Co., Ltd. 140-9, Yuram-ro, Dong-gu Daegu 41059 KR Other 510(k) Applications for this Company
Contact	Seok-Jun Ma Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	FCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2023
Decision Date	06/30/2023
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