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FDA 510(k)

Flexible Video-Choledochoscope System

K-Number: K222261 · 2023-04-20

ApplicantShanghai SeeGen Photoelectric Technology Co., Ltd.
Decision Date2023-04-20
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Flexible Video-Choledochoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-04-20 under 510(k) number K222261. 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 Video-Choledochoscope System?

Flexible Video-Choledochoscope System is a medical device that received FDA 510(k) clearance on 2023-04-20. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K222261.

When did Flexible Video-Choledochoscope System receive FDA 510(k) clearance?

Flexible Video-Choledochoscope System received FDA 510(k) clearance on 2023-04-20, under 510(k) number K222261.

Who is the listed applicant for Flexible Video-Choledochoscope System?

The FDA 510(k) record lists Shanghai SeeGen Photoelectric Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flexible Video-Choledochoscope System?

The FDA product code for Flexible Video-Choledochoscope System is FBN.

Other records listing Shanghai SeeGen Photoelectric Technology Co., Ltd. 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.

K252457Disposable Distal End Tape HoodK243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)K241532Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)K222499Disposable Endoscope Valves KitK211686Flexible Video-Choledo-Cysto-Ureteroscope System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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