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FDA 510(k)

Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)

K-Number: K231105 · 2023-10-17

ApplicantShanghai AnQing Medical Instrument Co., Ltd.
Decision Date2023-10-17
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-10-17 under 510(k) number K231105. 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 (Model: CS50H-20EU, CS50H-20US)?

Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) is a medical device that received FDA 510(k) clearance on 2023-10-17. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K231105.

When did Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) receive FDA 510(k) clearance?

Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) received FDA 510(k) clearance on 2023-10-17, under 510(k) number K231105.

Who is the listed applicant for Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)?

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

What is the FDA product code for Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)?

The FDA product code for Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) is FBN.

Other records listing Shanghai AnQing Medical Instrument 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.

K254251InnovexView (GC146-17, GC150-20, GC155-23)K252806Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)K251752Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)K243497Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28USK243857Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)

View all 14 devices →

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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