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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
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
1 Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact Dana Borris
Correspondent
Boston Scientific Corp
1 Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact Dana Borris
Regulation Number878.4350
Classification Product Code
GEH  
Date Received10/11/2024
Decision Date 10/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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