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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 the device name listed in this FDA 510(k) record. The listed applicant is Erbe USA, Inc.. It received FDA 510(k) clearance on 2019-05-23 under 510(k) 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. The listed applicant is Erbe USA, Inc.. The 510(k) number is K190469.

When did ERBEFLO 2 Disposable Tubing System receive FDA 510(k) clearance?

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

Who is the listed applicant for ERBEFLO 2 Disposable Tubing System?

The FDA 510(k) record lists Erbe USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Erbe USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221177Erbe's Tubing/Cap SetsK191438ERBEFLO 2 Endo Quick Connect Pentax Scope Port ConnectorK182444ERBEFLO Olympus Scope Port ConnectorK162152Erbe’s CO2 Tubing/Cap Sets

Related Devices (Code: OCX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251986AUXILIARY WATER TUBE MAJ-855Olympus Medical Systems CorporationK251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems CorporationK242586ArgoCap (200.52)Ovesco Endoscopy AGK241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems CorporationK241874Aspiration Catheter (2189)Hobbs Medical, Inc.

Official Source

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