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FDA 510(k)

Seal Single-Use Biopsy Valve

K-Number: K161167 · 2016-05-26

ApplicantEndochoice, Inc.
Decision Date2016-05-26
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Seal Single-Use Biopsy Valve is a medical device manufactured by Endochoice, Inc.. It received FDA 510(k) clearance on 2016-05-26 under approval number K161167. 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 Seal Single-Use Biopsy Valve?

Seal Single-Use Biopsy Valve is a medical device that received FDA 510(k) clearance on 2016-05-26. It is manufactured by Endochoice, Inc.. The 510(k) number is K161167.

When was Seal Single-Use Biopsy Valve approved by the FDA?

Seal Single-Use Biopsy Valve received FDA 510(k) clearance on 2016-05-26, under approval number K161167.

What company makes Seal Single-Use Biopsy Valve?

Seal Single-Use Biopsy Valve is manufactured by Endochoice, Inc..

What is the FDA product code for Seal Single-Use Biopsy Valve?

The FDA product code for Seal Single-Use Biopsy Valve is OCX.

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Other Devices by Endochoice, Inc.

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Related Devices (Code: OCX)

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. 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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