K241385
- 510(k) number
- K241385
- Device name
- Omnifix Syringe NRFit
- Applicant
- B.Braun Medical, Inc. PA · US
- Product code
- QEH — Piston Syringe With Neuraxial Connector Epidural,
- Decision date
- 2024-07-13
- Date received
- 2024-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241385.pdf
Official FDA record: K241385
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.