FDA 510(k) Application Details - K250066

Device Classification Name	More FDA Info for this Device
510(K) Number	K250066
Device Name	Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)
Applicant	Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 02472 US Other 510(k) Applications for this Company
Contact	Kyra McNamara Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2025
Decision Date	02/06/2025
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