510(k) K242664 · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
gentleheel® Adult Incision Device
| Applicant | Gri-Alleset, Inc., Flowery Branch GA, US |
| Decision | Substantially Equivalent, Nov 5, 2024 |
| Received | Sep 4, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242664
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.