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FDA 510(k)

CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION

K-Number: K933906 · 1994-07-08

ApplicantFujinon, Inc.
Decision Date1994-07-08
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Fujinon, Inc.. It received FDA 510(k) clearance on 1994-07-08 under 510(k) number K933906. 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/ENDOSCOPE MODIFICATION?

CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-07-08. The listed applicant is Fujinon, Inc.. The 510(k) number is K933906.

When did CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION receive FDA 510(k) clearance?

CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION received FDA 510(k) clearance on 1994-07-08, under 510(k) number K933906.

Who is the listed applicant for CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION?

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

What is the FDA product code for CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION?

The FDA product code for CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION is FBN.

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Other records listing Fujinon, 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.

K120446FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2K112391FUJINON COLONOSCOPESK102466FUJINON EPX-4440HD DIGITAL VIDEO PROCESSORK111243FUJINON ULTRASONIC PROCESSORK091773FUJINON STERILE OVERTUBESK090116FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15

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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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