K252886
- 510(k) number
- K252886
- Device name
- Pen Needle
- Applicant
- Hh Global Technology, Inc. GA · US
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2026-01-06
- Date received
- 2025-09-10
- 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: K252886.pdf
Official FDA record: K252886
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.