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FDA 510(k)

Disposable Trocar

K-Number: K202931 · 2020-11-17

ApplicantWuxi Shukang Medical Appliance Co., Ltd.
Decision Date2020-11-17
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Shukang Medical Appliance Co., Ltd.. It received FDA 510(k) clearance on 2020-11-17 under 510(k) number K202931. 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 Disposable Trocar?

Disposable Trocar is a medical device that received FDA 510(k) clearance on 2020-11-17. The listed applicant is Wuxi Shukang Medical Appliance Co., Ltd.. The 510(k) number is K202931.

When did Disposable Trocar receive FDA 510(k) clearance?

Disposable Trocar received FDA 510(k) clearance on 2020-11-17, under 510(k) number K202931.

Who is the listed applicant for Disposable Trocar?

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

What is the FDA product code for Disposable Trocar?

The FDA product code for Disposable Trocar is GCJ.

Related Devices (Code: GCJ)

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

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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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