FDA 510(k) Application Details - K233772

Device Classification Name	More FDA Info for this Device
510(K) Number	K233772
Device Name	Disposable Dual Action Tissue Closure Device
Applicant	Mirco-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Rd Nanjing National Hi-Tech, Industrial Development Zone Nanjing 210032 CN Other 510(k) Applications for this Company
Contact	He Sally 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	11/24/2023
Decision Date	03/19/2024
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