K130720 is an FDA 510(k) clearance for the SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on August 14, 2014, 514 days after receiving the submission on March 18, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K130720 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 2013 |
| Decision Date | August 14, 2014 |
| Days to Decision | 514 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 |