FDA 510(k) Application Details - K213633

Device Classification Name	Stapler, Surgical   More FDA Info for this Device
510(K) Number	K213633
Device Name	Stapler, Surgical
Applicant	Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 US Other 510(k) Applications for this Company
Contact	Nathan Anderson 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	11/17/2021
Decision Date	04/08/2022
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