HALYARD* ONE-STEP* Sterilization Wrap +3 more— 510(k) K253454
Substantially EquivalentO&M Halyard, Inc.
FDA 510(k) clearance K253454 for HALYARD* ONE-STEP* Sterilization Wrap +3 more, Substantially Equivalent on 2026-05-18. Applicant: O&M Halyard, Inc.. Device class: 2.
Clearance details
- Device name as filed
- HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap
- 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
Recent devices under product code FRG
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- K243604 — Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid
- K243172 — Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs +1 more
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.