K232370
- 510(k) number
- K232370
- Device name
- Percutaneous Nephroscope System
- Applicant
- Karl Storz SE & CO. KG DE
- Product code
- FGA — Kit, Nephroscope
- Decision date
- 2024-05-01
- Date received
- 2023-08-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K232370.pdf
Official FDA record: K232370
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.