FDA 510(k)

Endorate Valve Sets

K-Number: K181509 · 2018-07-06

Decision Date2018-07-06

Product CodeOCX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Endorate Valve Sets is a medical device manufactured by Smartdata Suzhou Co., Ltd.. It received FDA 510(k) clearance on 2018-07-06 under approval number K181509. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endorate Valve Sets?

Endorate Valve Sets is a medical device that received FDA 510(k) clearance on 2018-07-06. It is manufactured by Smartdata Suzhou Co., Ltd.. The 510(k) number is K181509.

When was Endorate Valve Sets approved by the FDA?

Endorate Valve Sets received FDA 510(k) clearance on 2018-07-06, under approval number K181509.

What company makes Endorate Valve Sets?

Endorate Valve Sets is manufactured by Smartdata Suzhou Co., Ltd..

What is the FDA product code for Endorate Valve Sets?

The FDA product code for Endorate Valve Sets is OCX.

Other Devices by Smartdata Suzhou Co., Ltd.

K191366Vacutore Air/Water Bottle Tubing K191231Andorate Auxiliary Water Connector, Andorate Valves Set K182998Andorate Auxiliary Water Connector

Related Devices (Code: OCX)

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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.