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FDA 510(k)

PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A

K-Number: K821974 · 1982-08-10

ApplicantPentax Precision Instrument Corp.
Decision Date1982-08-10
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Precision Instrument Corp.. It received FDA 510(k) clearance on 1982-08-10 under 510(k) number K821974. 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 PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A?

PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A is a medical device that received FDA 510(k) clearance on 1982-08-10. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K821974.

When did PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A receive FDA 510(k) clearance?

PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A received FDA 510(k) clearance on 1982-08-10, under 510(k) number K821974.

Who is the listed applicant for PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A?

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

What is the FDA product code for PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A?

The FDA product code for PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A is FBN.

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Other records listing Pentax Precision Instrument Corp. 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.

K041397EG-3830UTK041396FG-36UX FIBER ULTRASOUND GASTROSCOPEK041395EG-3630URK031789EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023401EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023376EB-1830T3, VIDEO BRONCHOSCOPE

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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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