FDA 510(k) Application Details - K231240

Device Classification Name	Endoscopic Tissue Approximation Device   More FDA Info for this Device
510(K) Number	K231240
Device Name	Endoscopic Tissue Approximation Device
Applicant	Covidien 60 Middletown Avenue North Haven, CT 06473 US Other 510(k) Applications for this Company
Contact	Megha Patel Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2023
Decision Date	09/08/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review