K243581
- 510(k) number
- K243581
- Device name
- K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
- Applicant
- Terumo Europe N.V. BE
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2025-04-04
- Date received
- 2024-11-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243581.pdf
Official FDA record: K243581
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.