510(k) K261897 ยท FRG Wrap, Sterilization
HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology
| Applicant | O&M Halyard, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Jul 2, 2026 |
| Received | Jun 5, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261897
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.