FDA 510(k) Application Details - K251759

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K251759
Device Name	Powered Laser Surgical Instrument
Applicant	Boston Scientific Corporation 100 Boston Scientific Way - Urology Division Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Galit Gershon Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	GEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/09/2025
Decision Date	07/09/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review