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FDA 510(k)

SCOPEVALET DISPOSABLE BIOPSY VALVE

K-Number: K122417 · 2013-05-17

ApplicantThe Ruhof Corp.
Decision Date2013-05-17
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SCOPEVALET DISPOSABLE BIOPSY VALVE is the device name listed in this FDA 510(k) record. The listed applicant is The Ruhof Corp.. It received FDA 510(k) clearance on 2013-05-17 under 510(k) number K122417. 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 SCOPEVALET DISPOSABLE BIOPSY VALVE?

SCOPEVALET DISPOSABLE BIOPSY VALVE is a medical device that received FDA 510(k) clearance on 2013-05-17. The listed applicant is The Ruhof Corp.. The 510(k) number is K122417.

When did SCOPEVALET DISPOSABLE BIOPSY VALVE receive FDA 510(k) clearance?

SCOPEVALET DISPOSABLE BIOPSY VALVE received FDA 510(k) clearance on 2013-05-17, under 510(k) number K122417.

Who is the listed applicant for SCOPEVALET DISPOSABLE BIOPSY VALVE?

The FDA 510(k) record lists The Ruhof Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCOPEVALET DISPOSABLE BIOPSY VALVE?

The FDA product code for SCOPEVALET DISPOSABLE BIOPSY VALVE is OCX.

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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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