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FDA 510(k)

Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)

K-Number: K252929 · 2026-04-09

ApplicantAnhui Happiness Workshop Instruments Co., Ltd.
Decision Date2026-04-09
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) is a medical device manufactured by Anhui Happiness Workshop Instruments Co., Ltd.. It received FDA 510(k) clearance on 2026-04-09 under approval number K252929. 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 Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)?

Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) is a medical device that received FDA 510(k) clearance on 2026-04-09. It is manufactured by Anhui Happiness Workshop Instruments Co., Ltd.. The 510(k) number is K252929.

When was Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) approved by the FDA?

Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) received FDA 510(k) clearance on 2026-04-09, under approval number K252929.

What company makes Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)?

Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) is manufactured by Anhui Happiness Workshop Instruments Co., Ltd..

What is the FDA product code for Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)?

The FDA product code for Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) is FGB.

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41883556 A clinician's quick‑start guide to implementing digital health innovations in the NHS - with lessons from a UK-deployed AI stroke imaging decision-support software. Digital health (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026)

Related Devices (Code: FGB)

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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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