K261897
- 510(k) number
- K261897
- Device name
- 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. GA · US
- Product code
- FRG — Wrap, Sterilization
- Decision date
- 2026-07-02
- Date received
- 2026-06-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K261897.pdf
Official FDA record: K261897
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.