K182084 is an FDA 510(k) clearance for the Sweden & Martina Surgical Tray (Model ZSHORTY-INT). This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Sweden & Martina S.P.A. (Due Carrare, IT). The FDA issued a Cleared decision on November 4, 2020, 825 days after receiving the submission on August 2, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K182084 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2018 |
| Decision Date | November 04, 2020 |
| Days to Decision | 825 days |
| Submission Type | Traditional |
| 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 |