K242208 is an FDA 510(k) clearance for the PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600). This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Primed Medical Products, Inc. (Edmonton, CA). The FDA issued a Cleared decision on October 7, 2024, 70 days after receiving the submission on July 29, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K242208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2024 |
| Decision Date | October 07, 2024 |
| Days to Decision | 70 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 |