K190541 is an FDA 510(k) clearance for the MTS225 and MTS300 Multiple Tray Sterilization Systems. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Pmbs, LLC (Gulfport, US). The FDA issued a Cleared decision on November 5, 2019, 246 days after receiving the submission on March 4, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K190541 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2019 |
| Decision Date | November 05, 2019 |
| 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 |