Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)— 510(k) K252929
Substantially EquivalentAnhui Happiness Workshop Instruments Co., Ltd.
FDA 510(k) clearance K252929 for Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200), Substantially Equivalent on 2026-04-09. Applicant: Anhui Happiness Workshop Instruments Co., Ltd..
Summary
The Single Use Digital Flexible Ureteroscope (7.5F) with Videoscope Imaging Processor is a disposable ureteroscope paired with a reusable image-processing console. Product code FGB covers flexible endoscopes used in urologic procedures — stone management, biopsy, and diagnostic visualization of the upper urinary tract. The single-use model has been gaining share from reusable Boston Scientific and Olympus scopes on sterilization-reliability grounds.
Gastroenterology, Urology panel, Traditional 510(k). FGB clearances for single-use ureteroscopes have risen steadily; the 7.5F outer diameter is the competitive size point.
Anhui Happiness Workshop Instruments Co. files from Bengbu, China. Seven-month review clock, in line with the category.
Clearance details
- Applicant
- Anhui Happiness Workshop Instruments Co., Ltd.
- Product code
- Code FGB
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bengbu, CN
Adverse events under product code FGB
product code FGB- Death
- 6
- Injury
- 552
- Malfunction
- 3,922
- Other
- 1
- Total
- 4,481
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.