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FDA 510(k)

Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)

K-Number: K243857 · 2025-04-11

ApplicantShanghai AnQing Medical Instrument Co., Ltd.
Decision Date2025-04-11
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) 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 2025-04-11 under 510(k) number K243857. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)?

Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K243857.

When did Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) receive FDA 510(k) clearance?

Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) received FDA 510(k) clearance on 2025-04-11, under 510(k) number K243857.

Who is the listed applicant for Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)?

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 Ureterorenoscope (US27F-12-EU; US27F-12-US)?

The FDA product code for Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) is FGB.

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-28USK231105Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)

View all 14 devices →

Related Devices (Code: FGB)

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.

K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)Anhui Happiness Workshop Instruments Co., Ltd.K260013CVAC Image ProcessorCalyxo, Inc.K252468Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)Zhejiang Geyi Medical Instrument 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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