K172292 is an FDA 510(k) clearance for the SALUS - Hygiene Instrument Reprocessing Container. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Scican , Ltd. (Toronto, CA). The FDA issued a Cleared decision on November 24, 2017, 116 days after receiving the submission on July 31, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K172292 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2017 |
| Decision Date | November 24, 2017 |
| Days to Decision | 116 days |
| Submission Type | Abbreviated |
| 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 |