K243721 is an FDA 510(k) clearance for the Self Sealing Sterilization Pouches. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Wellmed Dental Medical Supply Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 25, 2025, 143 days after receiving the submission on December 3, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K243721 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2024 |
| Decision Date | April 25, 2025 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRG - Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |