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FDA 510(k)

Erbe's Tubing/Cap Sets

K-Number: K221177 · 2022-08-11

ApplicantErbe USA, Inc.
Decision Date2022-08-11
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Erbe's Tubing/Cap Sets 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 2022-08-11 under 510(k) number K221177. 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 Erbe's Tubing/Cap Sets?

Erbe's Tubing/Cap Sets is a medical device that received FDA 510(k) clearance on 2022-08-11. The listed applicant is Erbe USA, Inc.. The 510(k) number is K221177.

When did Erbe's Tubing/Cap Sets receive FDA 510(k) clearance?

Erbe's Tubing/Cap Sets received FDA 510(k) clearance on 2022-08-11, under 510(k) number K221177.

Who is the listed applicant for Erbe's Tubing/Cap Sets?

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 Erbe's Tubing/Cap Sets?

The FDA product code for Erbe's Tubing/Cap Sets 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.

K191438ERBEFLO 2 Endo Quick Connect Pentax Scope Port ConnectorK190469ERBEFLO 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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