Identifiers
- 510(k) Number
- K253454 FDA 510(k)
- FDA Product Code
- FRG FDA 510(k)
- Models / Variants
- HALYARD* ONE-STEP* Sterilization Wrap FDA 510(k)HALYARD* QUICK CHECK* Sterilization Wrap FDA 510(k)HALYARD* SEQUENTIAL Sterilization Wrap FDA 510(k)HALYARD* SMART-FOLD* Sterilization Wrap FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6850 FDA 510(k)
- Regulation Number
- 880.6850 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Halyard Sterilization Wrap is a sterile barrier wrap designed for packaging medical instruments and devices to maintain sterility during storage and transport. It is categorized under the product code FRG and includes variants such as ONE-STEP, QUICK CHECK, SEQUENTIAL, and SMART-FOLD, each tailored for specific wrapping needs in clinical settings.
These wraps are supplied in bulk packages of single sheets, intended for use in general hospital environments. They are classified as substantially equivalent under FDA 510(k) clearance (K253454) and are reusable for wrapping instruments as per standard hospital protocols. No specific sterility or MRI safety details are provided, but compliance with regulatory standards ensures suitability for sterile barrier applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HALYARD* QUICK CHECK* Sterilization Wrap | HALYARD® Medical Products, QUICK CHECK* Sterilization Wrap - HALYARD Global Products, Produkte | HALYARD, PDF One-step Quick Check Interleaved Sequential Sterilisation Wrap
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253454 | Class II | Active |
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Manufacturer
- Manufacturer
- O&M Halyard, Inc.
Sources (1)
- FDA 510(k) K253454 24 fields · synced Sep 19, 2026