K251257
- 510(k) number
- K251257
- Device name
- nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]
- Applicant
- Np Medical MA · US
- Product code
- FPA — Set, Administration, Intravascular
- Decision date
- 2025-12-04
- Date received
- 2025-04-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K251257.pdf
Official FDA record: K251257
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.