K173259 is an FDA 510(k) clearance for the Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories. 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. (South Hackensack, US). The FDA issued a Cleared decision on June 13, 2018, 246 days after receiving the submission on October 10, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K173259 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2017 |
| Decision Date | June 13, 2018 |
| 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 |