K242898 is an FDA 510(k) clearance for the Sterilization Pouches and Reels. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Shanghai Jianzhong Medical Packaging Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 21, 2025, 151 days after receiving the submission on September 23, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K242898 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2024 |
| Decision Date | February 21, 2025 |
| Days to Decision | 151 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 |