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FDA 510(k)

SurBlate Ablation System

K-Number: K223272 · 2023-02-28

ApplicantMima-Pro Scientific, Inc.
Decision Date2023-02-28
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SurBlate Ablation System is a medical device manufactured by Mima-Pro Scientific, Inc.. It received FDA 510(k) clearance on 2023-02-28 under approval number K223272. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurBlate Ablation System?

SurBlate Ablation System is a medical device that received FDA 510(k) clearance on 2023-02-28. It is manufactured by Mima-Pro Scientific, Inc.. The 510(k) number is K223272.

When was SurBlate Ablation System approved by the FDA?

SurBlate Ablation System received FDA 510(k) clearance on 2023-02-28, under approval number K223272.

What company makes SurBlate Ablation System?

SurBlate Ablation System is manufactured by Mima-Pro Scientific, Inc..

What is the FDA product code for SurBlate Ablation System?

The FDA product code for SurBlate Ablation System is NEY.

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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.

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