FDA 510(k) Application Details - K250517

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K250517
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	Boston Scientific Corporation 100 Boston Scientific Way û Urology Division Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Timilehin Adenekan Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/21/2025
Decision Date	03/21/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review