K260208
- 510(k) number
- K260208
- Device name
- Ultra-Fine SAFETY Insulin Syringe
- Applicant
- embecta Medical II, LLC NJ · US
- Product code
- FMF — Syringe, Piston
- Decision date
- 2026-07-13
- Date received
- 2026-01-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K260208.pdf
Official FDA record: K260208
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.