FDA 510(k) Application Details - K231491

Device Classification Name	Stapler, Surgical   More FDA Info for this Device
510(K) Number	K231491
Device Name	Stapler, Surgical
Applicant	Covidien 60 Middletown Ave. North Haven, CT 06473 US Other 510(k) Applications for this Company
Contact	Emily Jacobs 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	05/23/2023
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	Traditional
Reviewed By Third Party	N
Expedited Review