FDA 510(k) Application Details - K251265

Device Classification Name	Prosthesis, Esophageal   More FDA Info for this Device
510(K) Number	K251265
Device Name	Prosthesis, Esophageal
Applicant	Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 US Other 510(k) Applications for this Company
Contact	David Thomas Other 510(k) Applications for this Contact
Regulation Number	878.3610   More FDA Info for this Regulation Number
Classification Product Code	ESW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/2025
Decision Date	07/23/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review