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FDA 510(k)

SEAL BIOPSY VALVE - REUSABLE

K-Number: K132776 · 2013-12-20

ApplicantEndochoice, Inc.
Decision Date2013-12-20
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SEAL BIOPSY VALVE - REUSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Endochoice, Inc.. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K132776. 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 SEAL BIOPSY VALVE - REUSABLE?

SEAL BIOPSY VALVE - REUSABLE is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Endochoice, Inc.. The 510(k) number is K132776.

When did SEAL BIOPSY VALVE - REUSABLE receive FDA 510(k) clearance?

SEAL BIOPSY VALVE - REUSABLE received FDA 510(k) clearance on 2013-12-20, under 510(k) number K132776.

Who is the listed applicant for SEAL BIOPSY VALVE - REUSABLE?

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

What is the FDA product code for SEAL BIOPSY VALVE - REUSABLE?

The FDA product code for SEAL BIOPSY VALVE - REUSABLE is OCX.

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Other records listing Endochoice, Inc. as applicant

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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

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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