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FDA 510(k)

FLEXIBLE CHOLEDOCHOSCOPE

K-Number: K901010 · 1990-05-22

ApplicantIntramed Laboratories, Inc.
Decision Date1990-05-22
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE CHOLEDOCHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Intramed Laboratories, Inc.. It received FDA 510(k) clearance on 1990-05-22 under 510(k) number K901010. 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 FLEXIBLE CHOLEDOCHOSCOPE?

FLEXIBLE CHOLEDOCHOSCOPE is a medical device that received FDA 510(k) clearance on 1990-05-22. The listed applicant is Intramed Laboratories, Inc.. The 510(k) number is K901010.

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

FLEXIBLE CHOLEDOCHOSCOPE received FDA 510(k) clearance on 1990-05-22, under 510(k) number K901010.

Who is the listed applicant for FLEXIBLE CHOLEDOCHOSCOPE?

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

What is the FDA product code for FLEXIBLE CHOLEDOCHOSCOPE?

The FDA product code for FLEXIBLE CHOLEDOCHOSCOPE is FBN.

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Other records listing Intramed Laboratories, 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.

K953258TITANIUM HEMOSTATIC CLIPK942457GRAFT THROMBECTOMY INSTRUMENTSK931792ARTHROSCOPEK925283VALVULOTOMEK934696ANGIOSCOPEK922114ENDOSCOPIC RETRIEVAL BASKET

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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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