K212711 is an FDA 510(k) clearance for the SteriTite Container System with MediTray Products. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Case Medical, Inc. (Bloomfield, US). The FDA issued a Cleared decision on April 29, 2022, 246 days after receiving the submission on August 26, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K212711 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2021 |
| Decision Date | April 29, 2022 |
| Days to Decision | 246 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 |