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FDA 510(k)

Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)

K-Number: K240196 · 2024-06-18

ApplicantYuwonmeditech Co., Ltd.
Decision Date2024-06-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) is a medical device manufactured by Yuwonmeditech Co., Ltd.. It received FDA 510(k) clearance on 2024-06-18 under approval number K240196. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)?

Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) is a medical device that received FDA 510(k) clearance on 2024-06-18. It is manufactured by Yuwonmeditech Co., Ltd.. The 510(k) number is K240196.

When was Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) approved by the FDA?

Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) received FDA 510(k) clearance on 2024-06-18, under approval number K240196.

What company makes Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)?

Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) is manufactured by Yuwonmeditech Co., Ltd..

What is the FDA product code for Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)?

The FDA product code for Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) is GCJ.

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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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