FDA 510(k) Application Details - K231934

Device Classification Name	Stapler, Surgical   More FDA Info for this Device
510(K) Number	K231934
Device Name	Stapler, Surgical
Applicant	Covidien Rooms 501,502,601,602, No.3 building, No.2388 Chen Hang Road Min Hang District, Shanghai 201114 CN Other 510(k) Applications for this Company
Contact	Leo Chen Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	GAG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/30/2023
Decision Date	10/27/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review