Visual-ICE Cryoablation System
FDA 510(k) K230551 · Boston Scientific Corporation
510(k) numberK230551
Submission
- Device name
- Visual-ICE Cryoablation System
- Applicant
- Boston Scientific Corporation
Maple Grove, MN, US - Received
- February 28, 2023
- Decision date
- August 8, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEH – Unit, Cryosurgical, Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4350
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Visual-ICE Cryoablation System cleared by the FDA?
Visual-ICE Cryoablation System (K230551) received a 510(k) decision of Substantially Equivalent on August 8, 2023, 161 days after the submission was received.
What is the product code of K230551?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.