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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 the device name listed in this FDA 510(k) record. The listed applicant is Erbe USA, Inc.. It received FDA 510(k) clearance on 2019-06-27 under 510(k) 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. The listed applicant is Erbe USA, Inc.. The 510(k) number is K191438.

When did ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector receive FDA 510(k) clearance?

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

Who is the listed applicant for ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector?

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 Endo Quick Connect Pentax Scope Port Connector?

The FDA product code for ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector 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 SetsK190469ERBEFLO 2 Disposable Tubing SystemK182444ERBEFLO 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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