Single-Use Flexible Cystoscope
K-Number: K221580 · 2022-11-18
Decision Date2022-11-18
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Single-Use Flexible Cystoscope is a medical device manufactured by Hunan Vathin Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-11-18 under approval number K221580. 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 Single-Use Flexible Cystoscope?
Single-Use Flexible Cystoscope is a medical device that received FDA 510(k) clearance on 2022-11-18. It is manufactured by Hunan Vathin Medical Instrument Co., Ltd.. The 510(k) number is K221580.
When was Single-Use Flexible Cystoscope approved by the FDA?
Single-Use Flexible Cystoscope received FDA 510(k) clearance on 2022-11-18, under approval number K221580.
What company makes Single-Use Flexible Cystoscope?
Single-Use Flexible Cystoscope is manufactured by Hunan Vathin Medical Instrument Co., Ltd..
What is the FDA product code for Single-Use Flexible Cystoscope?
The FDA product code for Single-Use Flexible Cystoscope is FAJ.
Other Devices by Hunan Vathin Medical Instrument 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.