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FDA 510(k)

Ureterorenoscope System

K-Number: K240374 · 2024-05-10

Decision Date2024-05-10
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ureterorenoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K240374. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ureterorenoscope System?

Ureterorenoscope System is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. The 510(k) number is K240374.

When did Ureterorenoscope System receive FDA 510(k) clearance?

Ureterorenoscope System received FDA 510(k) clearance on 2024-05-10, under 510(k) number K240374.

Who is the listed applicant for Ureterorenoscope System?

The FDA 510(k) record lists Shenzhen HugeMed Medical Technical Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ureterorenoscope System?

The FDA product code for Ureterorenoscope System is FGB.

Other records listing Shenzhen HugeMed Medical Technical Development 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.

View all 8 devices →

Related Devices (Code: FGB)

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.

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.