K251347 is an FDA 510(k) clearance for the Sterilization Pouch/Roll. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Sterivic Medical Co., Ltd. (Chizhou, CN). The FDA issued a Cleared decision on January 28, 2026, 273 days after receiving the submission on April 30, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K251347 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2025 |
| Decision Date | January 28, 2026 |
| Days to Decision | 273 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 |