Cleared Traditional

ICEfx Cryoablation System (FPRCH8000-02)

K234002 · Boston Scientific · Orthopedic
Mar 2024
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K234002 is an FDA 510(k) clearance for the ICEfx Cryoablation System (FPRCH8000-02), a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on March 13, 2024, 85 days after receiving the submission on December 19, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4350.

Submission Details

510(k) Number K234002 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2023
Decision Date March 13, 2024
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code GEH — Unit, Cryosurgical, Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4350

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