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.. Device class: 2.
Summary
This clearance pairs a single-use digital flexible ureteroscope (7.5 French) with a reusable image processor, the Model HV-200. Product code FGB covers flexible and rigid ureteroscopes and their accessories, used for kidney stone treatment and upper urinary tract diagnosis.
Class II, 21 CFR 876.1500. The Gastroenterology and Urology panel reviewed it as a Traditional 510(k).
Anhui Happiness Workshop Instruments filed from Bengbu, China. Review took 206 days (September 15, 2025 to April 9, 2026). Single-use scopes skip the reprocessing that reusable ones need, which has made them a busy corner of FGB.
Clearance details
- Applicant
- Anhui Happiness Workshop Instruments Co., Ltd.
- Product code
- Code FGB
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bengbu, CN
Recent devices under product code FGB
view all- K262488 — Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
- K261153 — LithoVue Elite Digital Flexible Ureteroscope System
- K262552 — Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
- K253505 — Zamenix P
- K260516 — BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
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.