FDA 510(k) Application Details - K213338

Device Classification Name	More FDA Info for this Device
510(K) Number	K213338
Device Name	CORE-CLIP
Applicant	Incore Co., Ltd. 11, Hyeoksin-daero, 78-gil, Dong-gu Daegu 41072 KR Other 510(k) Applications for this Company
Contact	Jae-Hun Lee Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/2021
Decision Date	06/23/2022
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