K240330 is an FDA 510(k) clearance for the HALYARD* SMART-FOLD* Sterilization Wrap (H450). This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by O&M Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on August 7, 2024, 184 days after receiving the submission on February 5, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K240330 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2024 |
| Decision Date | August 07, 2024 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |