FDA 510(k) Application Details - K234039

Device Classification Name	Stapler, Surgical   More FDA Info for this Device
510(K) Number	K234039
Device Name	Stapler, Surgical
Applicant	Lexington Medical, Inc. 23 Crosby Drive Bedford, MA 01730 US Other 510(k) Applications for this Company
Contact	Sali Gully 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	12/21/2023
Decision Date	05/07/2024
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