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FDA 510(k)

FCP-9P, FIBER CHOLEDOCHOSCOPE

K-Number: K953286 · 1995-11-03

ApplicantPentax Precision Instrument Corp.
Decision Date1995-11-03
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FCP-9P, FIBER CHOLEDOCHOSCOPE 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 1995-11-03 under 510(k) number K953286. 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 FCP-9P, FIBER CHOLEDOCHOSCOPE?

FCP-9P, FIBER CHOLEDOCHOSCOPE is a medical device that received FDA 510(k) clearance on 1995-11-03. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K953286.

When did FCP-9P, FIBER CHOLEDOCHOSCOPE receive FDA 510(k) clearance?

FCP-9P, FIBER CHOLEDOCHOSCOPE received FDA 510(k) clearance on 1995-11-03, under 510(k) number K953286.

Who is the listed applicant for FCP-9P, FIBER CHOLEDOCHOSCOPE?

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 FCP-9P, FIBER CHOLEDOCHOSCOPE?

The FDA product code for FCP-9P, FIBER CHOLEDOCHOSCOPE 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-3830UTK041395EG-3630URK041396FG-36UX FIBER ULTRASOUND GASTROSCOPEK031789EG-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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