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FDA 510(k)

KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE

K-Number: K942112 · 1995-02-28

ApplicantKarl Storz Endoscopy
Decision Date1995-02-28
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy. It received FDA 510(k) clearance on 1995-02-28 under 510(k) number K942112. 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 KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE?

KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE is a medical device that received FDA 510(k) clearance on 1995-02-28. The listed applicant is Karl Storz Endoscopy. The 510(k) number is K942112.

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

KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE received FDA 510(k) clearance on 1995-02-28, under 510(k) number K942112.

Who is the listed applicant for KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE?

The FDA 510(k) record lists Karl Storz Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE?

The FDA product code for KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE is FBN.

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Other records listing Karl Storz Endoscopy 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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