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FDA 510(k)

TRAUS ENDO

K-Number: K212043 · 2022-06-24

ApplicantSaeshin Precision Co., Ltd.
Decision Date2022-06-24
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRAUS ENDO is the device name listed in this FDA 510(k) record. The listed applicant is Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2022-06-24 under 510(k) number K212043. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAUS ENDO?

TRAUS ENDO is a medical device that received FDA 510(k) clearance on 2022-06-24. The listed applicant is Saeshin Precision Co., Ltd.. The 510(k) number is K212043.

When did TRAUS ENDO receive FDA 510(k) clearance?

TRAUS ENDO received FDA 510(k) clearance on 2022-06-24, under 510(k) number K212043.

Who is the listed applicant for TRAUS ENDO?

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

What is the FDA product code for TRAUS ENDO?

The FDA product code for TRAUS ENDO is EKX.

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Related Devices (Code: EKX)

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.

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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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