K243179 is an FDA 510(k) clearance for the Sterilization Pouch and Roll. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Yichang Xinxin Paper Products Co., Ltd. (Yichang City, CN). The FDA issued a Cleared decision on June 26, 2025, 269 days after receiving the submission on September 30, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K243179 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2024 |
| Decision Date | June 26, 2025 |
| Days to Decision | 269 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 |