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 a medical device manufactured by Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2022-06-24 under approval 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. It is manufactured by Saeshin Precision Co., Ltd.. The 510(k) number is K212043.
When was TRAUS ENDO approved by the FDA?
TRAUS ENDO received FDA 510(k) clearance on 2022-06-24, under approval number K212043.
What company makes TRAUS ENDO?
TRAUS ENDO is manufactured by Saeshin Precision Co., Ltd..
What is the FDA product code for TRAUS ENDO?
The FDA product code for TRAUS ENDO is EKX.
Other Devices by Saeshin Precision Co., Ltd.
Related Devices (Code: EKX)
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.