K240203
- 510(k) number
- K240203
- Device name
- URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)
- Applicant
- Dyne Medical Group, Inc. KR
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2024-09-05
- Date received
- 2024-01-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K240203.pdf
Official FDA record: K240203
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.