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FDA 510(k)

Disposable Biopsy Valve

K-Number: K173758 · 2018-05-14

ApplicantZhejiang Chuangxiang Medical Technology Co., Ltd.
Decision Date2018-05-14
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Biopsy Valve is a medical device manufactured by Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-05-14 under approval number K173758. 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 Disposable Biopsy Valve?

Disposable Biopsy Valve is a medical device that received FDA 510(k) clearance on 2018-05-14. It is manufactured by Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K173758.

When was Disposable Biopsy Valve approved by the FDA?

Disposable Biopsy Valve received FDA 510(k) clearance on 2018-05-14, under approval number K173758.

What company makes Disposable Biopsy Valve?

Disposable Biopsy Valve is manufactured by Zhejiang Chuangxiang Medical Technology Co., Ltd..

What is the FDA product code for Disposable Biopsy Valve?

The FDA product code for Disposable Biopsy Valve is OCX.

Other Devices by Zhejiang Chuangxiang Medical Technology Co., Ltd.

K172762Single Use Hemoclip K172758Rotatable Snares, Non-Rotatable Snares K192258Disposable Valve Sets K191900Single Use Grasping Forceps K220063Single Use Cytology Brush K212669Single Use Hemoclip

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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. K171637OpClear SystemCipher Surgical, Ltd.

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.

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