Ureterorenoscope System
K-Number: K240374 · 2024-05-10
Decision Date2024-05-10
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Ureterorenoscope System is a medical device manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd.. It received FDA 510(k) clearance on 2024-05-10 under approval 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. It is manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd.. The 510(k) number is K240374.
When was Ureterorenoscope System approved by the FDA?
Ureterorenoscope System received FDA 510(k) clearance on 2024-05-10, under approval number K240374.
What company makes Ureterorenoscope System?
Ureterorenoscope System is manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd..
What is the FDA product code for Ureterorenoscope System?
The FDA product code for Ureterorenoscope System is FGB.
Other Devices by Shenzhen HugeMed Medical Technical Development Co., Ltd.
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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.