K193603 is an FDA 510(k) clearance for the Benesta Medical Sterilization Tray. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Caldera Medical, Inc. (Agoura Hills, US). The FDA issued a Cleared decision on July 20, 2020, 210 days after receiving the submission on December 23, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K193603 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2019 |
| Decision Date | July 20, 2020 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |