510(k) K233796 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)
| Applicant | SteriLance Medical (Suzhou), Inc., Suzhou, CN |
| Decision | Substantially Equivalent, Jan 16, 2024 |
| Received | Nov 29, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233796
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.