Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Shanghai AnQing Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-04-11 under approval 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. It is manufactured by Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K243857.

When was Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) approved by the FDA?

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

What company makes Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)?

Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) is manufactured by Shanghai AnQing Medical Instrument Co., Ltd..

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 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)

View all 14 devices →

Related Devices (Code: FGB)

K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. K171076Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. K181977WiScope Digital Endoscope SystemOTU Medical, Inc. K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. K172246OLYMPUS URF-V2/V2ROlympus Medical Systems Corp. K172298OLYMPUS URF-P6/P6ROlympus Medical Systems Corp.

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.

↑