K241434
- 510(k) number
- K241434
- Device name
- Video Ureteroscope System
- Applicant
- Hunan Vathin Medical Instrument Co., Ltd. CN
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2024-10-04
- Date received
- 2024-05-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K241434
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.