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FDA 510(k)

OLYMPUS XCHF TYPE B180Y1

K-Number: K080586 · 2008-05-06

ApplicantOlympus Medical Systems Corporation
Decision Date2008-05-06
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS XCHF TYPE B180Y1 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2008-05-06 under 510(k) number K080586. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS XCHF TYPE B180Y1?

OLYMPUS XCHF TYPE B180Y1 is a medical device that received FDA 510(k) clearance on 2008-05-06. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K080586.

When did OLYMPUS XCHF TYPE B180Y1 receive FDA 510(k) clearance?

OLYMPUS XCHF TYPE B180Y1 received FDA 510(k) clearance on 2008-05-06, under 510(k) number K080586.

Who is the listed applicant for OLYMPUS XCHF TYPE B180Y1?

The FDA 510(k) record lists Olympus Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS XCHF TYPE B180Y1?

The FDA product code for OLYMPUS XCHF TYPE B180Y1 is FBN.

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Other records listing Olympus Medical Systems Corporation 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.

K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)K260824Gastrointestinal Videoscope Olympus GIF-2T1500K260856Disposable Distal Attachment D-201-13404K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K261260HD Camera Head OLYMPUS CH-S200-08-LBK252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

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Related Devices (Code: FBN)

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.

K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.K253139Disposable Distal CapMirco-Tech (Nanjing) Co., Ltd.K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)Scivita Medical Technology Co., Ltd.K251170Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital ControllerTangent Endoscopy, LLCK243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)Shanghai SeeGen Photoelectric Technology Co., Ltd.K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.

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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