K250321 is an FDA 510(k) clearance for the GCI Sterilization Wrappers. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by George Courey, Inc. (Laval, CA). The FDA issued a Cleared decision on June 6, 2025, 122 days after receiving the submission on February 4, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K250321 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2025 |
| Decision Date | June 06, 2025 |
| Days to Decision | 122 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 |