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FDA 510(k)

Single-Use Biopsy Valve (MAJ-1555)

K-Number: K251997 · 2025-09-25

ApplicantOlympus Medical Systems Corporation
Decision Date2025-09-25
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single-Use Biopsy Valve (MAJ-1555) is a medical device manufactured by Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-09-25 under approval number K251997. 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 Single-Use Biopsy Valve (MAJ-1555)?

Single-Use Biopsy Valve (MAJ-1555) is a medical device that received FDA 510(k) clearance on 2025-09-25. It is manufactured by Olympus Medical Systems Corporation. The 510(k) number is K251997.

When was Single-Use Biopsy Valve (MAJ-1555) approved by the FDA?

Single-Use Biopsy Valve (MAJ-1555) received FDA 510(k) clearance on 2025-09-25, under approval number K251997.

What company makes Single-Use Biopsy Valve (MAJ-1555)?

Single-Use Biopsy Valve (MAJ-1555) is manufactured by Olympus Medical Systems Corporation.

What is the FDA product code for Single-Use Biopsy Valve (MAJ-1555)?

The FDA product code for Single-Use Biopsy Valve (MAJ-1555) is OCX.

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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. K173758Disposable Biopsy ValveZhejiang Chuangxiang Medical Technology Co., 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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