Cystoscope System
K-Number: K231118 · 2023-11-13
Decision Date2023-11-13
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Cystoscope System is a medical device manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd.. It received FDA 510(k) clearance on 2023-11-13 under approval number K231118. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cystoscope System?
Cystoscope System is a medical device that received FDA 510(k) clearance on 2023-11-13. It is manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd.. The 510(k) number is K231118.
When was Cystoscope System approved by the FDA?
Cystoscope System received FDA 510(k) clearance on 2023-11-13, under approval number K231118.
What company makes Cystoscope System?
Cystoscope System is manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd..
What is the FDA product code for Cystoscope System?
The FDA product code for Cystoscope System is FAJ.
Other Devices by Shenzhen HugeMed Medical Technical Development Co., Ltd.
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K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope SheathHenke-Sass, Wolf GmbH
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Official Source
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