FDA 510(k) Application Details - K234002

Device Classification Name	Unit, Cryosurgical, Accessories   More FDA Info for this Device
510(K) Number	K234002
Device Name	Unit, Cryosurgical, Accessories
Applicant	Boston Scientific 1 SciMed Place Maple Grove, MN 55311 US Other 510(k) Applications for this Company
Contact	Benjamin Van Santen Other 510(k) Applications for this Contact
Regulation Number	878.4350   More FDA Info for this Regulation Number
Classification Product Code	GEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2023
Decision Date	03/13/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review