K251756 is an FDA 510(k) clearance for the Sterilization Trays. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Paragon Implant Mfg., LLC (Calabasas, US). The FDA issued a Cleared decision on November 14, 2025, 158 days after receiving the submission on June 9, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K251756 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2025 |
| Decision Date | November 14, 2025 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KCT - Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |