K161415 is an FDA 510(k) clearance for the SteriTite Containers System & MediTray Products. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Case Medical, Inc. (South Hackensack, US). The FDA issued a Cleared decision on February 10, 2017, 263 days after receiving the submission on May 23, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K161415 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2016 |
| Decision Date | February 10, 2017 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG - Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |