K181933 is an FDA 510(k) clearance for the DePuy Synthes 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 / Depuy Orthopaedics, Inc. (West Chester, US). The FDA issued a Cleared decision on May 9, 2019, 294 days after receiving the submission on July 19, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K181933 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2018 |
| Decision Date | May 09, 2019 |
| Days to Decision | 294 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 |