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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 the device name listed in this FDA 510(k) record. The listed applicant is Yuwonmeditech Co., Ltd.. It received FDA 510(k) clearance on 2024-06-18 under 510(k) 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. The listed applicant is Yuwonmeditech Co., Ltd.. The 510(k) number is K240196.

When did Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) receive FDA 510(k) clearance?

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

Who is the listed applicant for Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)?

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

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

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

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