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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 the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2024-12-17 under 510(k) 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. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K241801.

When did Tornus ES receive FDA 510(k) clearance?

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

Who is the listed applicant for Tornus ES?

The FDA 510(k) record lists Asahi Intecc Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tornus ES?

The FDA product code for Tornus ES is FGE.

Other records listing Asahi Intecc Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 45 devices →

Related Devices (Code: FGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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