Atlas FDA

Visual-ICE Cryoablation System

FDA 510(k) clearance K230551 · decided 2023-08-08

Clearance details

K-number
K230551
Device name
Visual-ICE Cryoablation System
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2023-02-28
Decision date
2023-08-08
Days to decision
161 days
Clearance type
Traditional
Product code
GEH
Device class
2
Regulation number
878.4350
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Maple Grove, MN, US
Third-party review
No
Expedited review
No

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TargetCool-e (K253348)Recensmedical, Inc.2025-10-15
Verruca-Freeze H Plus (K252903)Cryosurgery, Inc.2025-10-10

Recalls involving this device

No recalls on record reference this clearance.

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