FDA 510(k)

Visual-ICE Cryoablation System

K-Number: K230551 · 2023-08-08

Decision Date2023-08-08

Product CodeGEH

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Visual-ICE Cryoablation System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-08-08 under 510(k) number K230551. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Visual-ICE Cryoablation System?

Visual-ICE Cryoablation System is a medical device that received FDA 510(k) clearance on 2023-08-08. The listed applicant is Boston Scientific Corporation. The 510(k) number is K230551.

When did Visual-ICE Cryoablation System receive FDA 510(k) clearance?

Visual-ICE Cryoablation System received FDA 510(k) clearance on 2023-08-08, under 510(k) number K230551.

Who is the listed applicant for Visual-ICE Cryoablation System?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Visual-ICE Cryoablation System?

The FDA product code for Visual-ICE Cryoablation System is GEH.

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Related Devices (Code: GEH)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.