510(k) K253454 ยท FRG Wrap, Sterilization
HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap
| Applicant | O&M Halyard, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, May 18, 2026 |
| Received | Oct 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253454
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.