FDA 510(k) Application Details - K202333

Device Classification Name	More FDA Info for this Device
510(K) Number	K202333
Device Name	Lockado Repositionable Hemostasis Clip
Applicant	Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road Nanjing 210032 CN Other 510(k) Applications for this Company
Contact	Sally He 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	08/17/2020
Decision Date	01/14/2021
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