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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 a medical device manufactured by Hunan Endoso Life Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-10-16 under approval 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. It is manufactured by Hunan Endoso Life Technology Co., Ltd.. The 510(k) number is K231725.

When was Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) approved by the FDA?

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

What company makes Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)?

Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) is manufactured by Hunan Endoso Life Technology Co., Ltd..

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 Devices by Hunan Endoso Life Technology Co., Ltd.

K231107Bronchoscope System K241956Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)

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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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