K153554 is an FDA 510(k) clearance for the Genesis Low Temperature Reusable Rigid Container System. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Carefusion 2200, Inc. (Vernon Hills, US). The FDA issued a Cleared decision on March 21, 2016, 98 days after receiving the submission on December 14, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K153554 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2015 |
| Decision Date | March 21, 2016 |
| Days to Decision | 98 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 |