FDA 510(k)

Andorate Auxiliary Water Connector

K-Number: K182998 · 2019-04-17

Decision Date2019-04-17

Product CodeOCX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Andorate Auxiliary Water Connector is a medical device manufactured by Smartdata Suzhou Co., Ltd.. It received FDA 510(k) clearance on 2019-04-17 under approval number K182998. 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 Andorate Auxiliary Water Connector?

Andorate Auxiliary Water Connector is a medical device that received FDA 510(k) clearance on 2019-04-17. It is manufactured by Smartdata Suzhou Co., Ltd.. The 510(k) number is K182998.

When was Andorate Auxiliary Water Connector approved by the FDA?

Andorate Auxiliary Water Connector received FDA 510(k) clearance on 2019-04-17, under approval number K182998.

What company makes Andorate Auxiliary Water Connector?

Andorate Auxiliary Water Connector is manufactured by Smartdata Suzhou Co., Ltd..

What is the FDA product code for Andorate Auxiliary Water Connector?

The FDA product code for Andorate Auxiliary Water Connector is OCX.

Other Devices by Smartdata Suzhou Co., Ltd.

K181509Endorate Valve Sets K191366Vacutore Air/Water Bottle Tubing K191231Andorate Auxiliary Water Connector, Andorate Valves Set

Related Devices (Code: OCX)

K161167Seal Single-Use Biopsy ValveEndochoice, Inc. K152278ENDOFLOW II - Irrigation, Warming and Suction SystemPromepla Sam K182444ERBEFLO Olympus Scope Port ConnectorErbe USA, Inc. K182275Seal Single Use Biopsy ValveBoston Scientific Corporation K181509Endorate Valve SetsSmartdata Suzhou Co., Ltd. K173758Disposable Biopsy ValveZhejiang Chuangxiang Medical Technology Co., Ltd.

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.