FDA 510(k)

Tornus ES

K-Number: K241801 · 2024-12-17

Decision Date2024-12-17

Product CodeFGE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Tornus ES is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2024-12-17 under approval number K241801. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tornus ES?

Tornus ES is a medical device that received FDA 510(k) clearance on 2024-12-17. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K241801.

When was Tornus ES approved by the FDA?

Tornus ES received FDA 510(k) clearance on 2024-12-17, under approval number K241801.

What company makes Tornus ES?

Tornus ES is manufactured by Asahi Intecc Co., Ltd..

What is the FDA product code for Tornus ES?

The FDA product code for Tornus ES is FGE.

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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.