K252929
- 510(k) number
- K252929
- Device name
- Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)
- Applicant
- Anhui Happiness Workshop Instruments Co., Ltd. CN
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2026-04-09
- Date received
- 2025-09-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K252929.pdf
Official FDA record: K252929
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.