K242839 is an FDA 510(k) clearance for the Safe Secure Sterilization Pouches and Rolls. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 16, 2024, 27 days after receiving the submission on September 19, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K242839 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2024 |
| Decision Date | October 16, 2024 |
| Days to Decision | 27 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 |