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FDA 510(k)

ERBEFLO 2 Disposable Tubing System

K-Number: K190469 · 2019-05-23

ApplicantErbe USA, Inc.
Decision Date2019-05-23
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ERBEFLO 2 Disposable Tubing System is a medical device manufactured by Erbe USA, Inc.. It received FDA 510(k) clearance on 2019-05-23 under approval number K190469. 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 ERBEFLO 2 Disposable Tubing System?

ERBEFLO 2 Disposable Tubing System is a medical device that received FDA 510(k) clearance on 2019-05-23. It is manufactured by Erbe USA, Inc.. The 510(k) number is K190469.

When was ERBEFLO 2 Disposable Tubing System approved by the FDA?

ERBEFLO 2 Disposable Tubing System received FDA 510(k) clearance on 2019-05-23, under approval number K190469.

What company makes ERBEFLO 2 Disposable Tubing System?

ERBEFLO 2 Disposable Tubing System is manufactured by Erbe USA, Inc..

What is the FDA product code for ERBEFLO 2 Disposable Tubing System?

The FDA product code for ERBEFLO 2 Disposable Tubing System is OCX.

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Other Devices by Erbe USA, Inc.

K162152Erbe’s CO2 Tubing/Cap Sets K182444ERBEFLO Olympus Scope Port Connector K191438ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector K221177Erbe's Tubing/Cap Sets

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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