510(k) K262427 ยท FMI Needle, Hypodermic, Single Lumen
Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type
| Applicant | Hh Global Technology, Inc., Buford GA, US |
| Decision | Substantially Equivalent, Aug 10, 2026 |
| Received | Jul 16, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K262427
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.