K231702
- 510(k) number
- K231702
- Device name
- WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet
- Applicant
- OTU Medical, Inc. CA · US
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2023-09-29
- Date received
- 2023-06-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231702.pdf
Official FDA record: K231702
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.