K233275
- 510(k) number
- K233275
- Device name
- RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)
- Applicant
- Gyrus Acmi, Inc. MN · US
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2024-03-25
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K233275.pdf
Official FDA record: K233275
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.