K243309
- 510(k) number
- K243309
- Device name
- 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
- Applicant
- Terumo Europe N.V. BE
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2025-05-29
- Date received
- 2024-10-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K243309.pdf
Official FDA record: K243309
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.