Cleared Special

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

K243245 · Boston Scientific Corp · General & Plastic Surgery

Oct 2024

Decision

Days

Class 2

Risk

About This 510(k) Submission

K243245 is an FDA 510(k) clearance for the IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330), a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on October 18, 2024, 7 days after receiving the submission on October 11, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.

Submission Details

510(k) Number	K243245 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 11, 2024
Decision Date	October 18, 2024
Days to Decision	7 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF