K253454
- 510(k) number
- K253454
- Device name
- HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap
- Applicant
- O&M Halyard, Inc. GA · US
- Product code
- FRG — Wrap, Sterilization
- Decision date
- 2026-05-18
- Date received
- 2025-10-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 6.2 MB · U.S. public domain
Also available from FDA: K253454.pdf
Official FDA record: K253454
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.