Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)
FDA 510(k) clearance K252929 · decided 2026-04-09
Clearance details
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-15
- Decision date
- 2026-04-09
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- FGB
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bengbu, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.