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FDA 510(k)

Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF

K-Number: K183188 · 2019-05-03

Decision Date2019-05-03
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF is a medical device manufactured by Richard Wolf Medical Instruments Corporation. It received FDA 510(k) clearance on 2019-05-03 under approval number K183188. 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 Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF?

Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF is a medical device that received FDA 510(k) clearance on 2019-05-03. It is manufactured by Richard Wolf Medical Instruments Corporation. The 510(k) number is K183188.

When was Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF approved by the FDA?

Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF received FDA 510(k) clearance on 2019-05-03, under approval number K183188.

What company makes Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF?

Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF is manufactured by Richard Wolf Medical Instruments Corporation.

What is the FDA product code for Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF?

The FDA product code for Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF is FGB.

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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.