K230137 is an FDA 510(k) clearance for the Reliance® Fusion Sterilization Wraps. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Ahlstrom-Munksjo Nonwovens, LLC (Windsor Locks, US). The FDA issued a Cleared decision on December 7, 2023, 323 days after receiving the submission on January 18, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K230137 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2023 |
| Decision Date | December 07, 2023 |
| Days to Decision | 323 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 |