K231118
- 510(k) number
- K231118
- Device name
- Cystoscope System
- Applicant
- Shenzhen HugeMed Medical Technical Development Co., Ltd. CN
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2023-11-13
- Date received
- 2023-04-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K231118.pdf
Official FDA record: K231118
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.