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FDA 510(k)

ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector

K-Number: K191438 · 2019-06-27

ApplicantErbe USA, Inc.
Decision Date2019-06-27
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector is a medical device manufactured by Erbe USA, Inc.. It received FDA 510(k) clearance on 2019-06-27 under approval number K191438. 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 Endo Quick Connect Pentax Scope Port Connector?

ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector is a medical device that received FDA 510(k) clearance on 2019-06-27. It is manufactured by Erbe USA, Inc.. The 510(k) number is K191438.

When was ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector approved by the FDA?

ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector received FDA 510(k) clearance on 2019-06-27, under approval number K191438.

What company makes ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector?

ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector is manufactured by Erbe USA, Inc..

What is the FDA product code for ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector?

The FDA product code for ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector is OCX.

Other Devices by Erbe USA, Inc.

K162152Erbe’s CO2 Tubing/Cap Sets K182444ERBEFLO Olympus Scope Port Connector K190469ERBEFLO 2 Disposable Tubing System 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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