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FDA 510(k)

Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)

K-Number: K231725 · 2023-10-16

ApplicantHunan Endoso Life Technology Co., Ltd.
Decision Date2023-10-16
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Endoso Life Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-10-16 under 510(k) number K231725. 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 Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)?

Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) is a medical device that received FDA 510(k) clearance on 2023-10-16. The listed applicant is Hunan Endoso Life Technology Co., Ltd.. The 510(k) number is K231725.

When did Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) receive FDA 510(k) clearance?

Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) received FDA 510(k) clearance on 2023-10-16, under 510(k) number K231725.

Who is the listed applicant for Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)?

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

What is the FDA product code for Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)?

The FDA product code for Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) is GCJ.

Other records listing Hunan Endoso Life Technology Co., Ltd. as applicant

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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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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