HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology +3 more— 510(k) K261897
Substantially EquivalentO&M Halyard, Inc.
FDA 510(k) clearance K261897 for HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology +3 more, Substantially Equivalent on 2026-07-02. Applicant: O&M Halyard, Inc.. Device class: 2.
Clearance details
- Device name as filed
- 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.
- Product code
- Code FRG
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
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Adverse events under product code FRG
product code FRG- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.