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FDA 510(k)

CHOLEDOCHOSCOPE SYSTEM

K-Number: K771367 · 1977-08-02

ApplicantRichard Wolf Medical Instruments Corp.
Decision Date1977-08-02
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CHOLEDOCHOSCOPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 1977-08-02 under 510(k) number K771367. 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 CHOLEDOCHOSCOPE SYSTEM?

CHOLEDOCHOSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 1977-08-02. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K771367.

When did CHOLEDOCHOSCOPE SYSTEM receive FDA 510(k) clearance?

CHOLEDOCHOSCOPE SYSTEM received FDA 510(k) clearance on 1977-08-02, under 510(k) number K771367.

Who is the listed applicant for CHOLEDOCHOSCOPE SYSTEM?

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

What is the FDA product code for CHOLEDOCHOSCOPE SYSTEM?

The FDA product code for CHOLEDOCHOSCOPE SYSTEM is FBN.

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Other records listing Richard Wolf Medical Instruments Corp. as applicant

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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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