K243245

IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)

510(k) number: K243245
Device name: IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)
Applicant: Boston Scientific Corp MN · US
Product code: GEH — Unit, Cryosurgical, Accessories
Decision date: 2024-10-18
Date received: 2024-10-11
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: General, Plastic Surgery

Also available from FDA: K243245.pdf

Official FDA record: K243245

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.