FDA 510(k) Application Details - K232126

Device Classification Name	Stapler, Surgical   More FDA Info for this Device
510(K) Number	K232126
Device Name	Stapler, Surgical
Applicant	Covidien Room 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	Helen 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	07/17/2023
Decision Date	08/16/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review