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FDA 510(k)

Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)

K-Number: K252598 · 2025-09-15

ApplicantShanghai AnQing Medical Instrument Co., Ltd.
Decision Date2025-09-15
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) is a medical device manufactured by Shanghai AnQing Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-09-15 under approval number K252598. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)?

Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) is a medical device that received FDA 510(k) clearance on 2025-09-15. It is manufactured by Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K252598.

When was Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) approved by the FDA?

Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) received FDA 510(k) clearance on 2025-09-15, under approval number K252598.

What company makes Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)?

Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) is manufactured by Shanghai AnQing Medical Instrument Co., Ltd..

What is the FDA product code for Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)?

The FDA product code for Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) is FAJ.

Other Devices by Shanghai AnQing Medical Instrument Co., Ltd.

K180367Ureterorenoscope System K181545Hysteroscope System K201293Ureterorenoscope System K211169Bronchoscope System K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) K222737Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)

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Related Devices (Code: FAJ)

K160766Ambu USR, Ambu MAmbu A/S K170862Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree CystoscopeSolace Therapeutics, Inc. K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope SheathHenke-Sass, Wolf GmbH K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc. K171500Uro-V CystoscopeUroviu Corporation K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.

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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