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FDA 510(k)

Disposable Laparoscopic Trocar

K-Number: K231042 · 2023-06-08

ApplicantChangzhou Ankang Medical Instruments Co., Ltd.
Decision Date2023-06-08
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Laparoscopic Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Ankang Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2023-06-08 under 510(k) number K231042. 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 Laparoscopic Trocar?

Disposable Laparoscopic Trocar is a medical device that received FDA 510(k) clearance on 2023-06-08. The listed applicant is Changzhou Ankang Medical Instruments Co., Ltd.. The 510(k) number is K231042.

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

Disposable Laparoscopic Trocar received FDA 510(k) clearance on 2023-06-08, under 510(k) number K231042.

Who is the listed applicant for Disposable Laparoscopic Trocar?

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

What is the FDA product code for Disposable Laparoscopic Trocar?

The FDA product code for Disposable Laparoscopic 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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