K251877
- 510(k) number
- K251877
- Device name
- JMS CAVEO A.V. Fistula Needle Set
- Applicant
- JMS North America Corporation CA · US
- Product code
- FIE — Needle, Fistula
- Decision date
- 2025-08-15
- Date received
- 2025-06-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K251877.pdf
Official FDA record: K251877
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.