K243431 is an FDA 510(k) clearance for the Medicom Sterilization Pouch and Reel. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. (Yilan County, TW). The FDA issued a Cleared decision on February 21, 2025, 108 days after receiving the submission on November 5, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K243431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2024 |
| Decision Date | February 21, 2025 |
| Days to Decision | 108 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 |