K160574 is an FDA 510(k) clearance for the K3PRO SURGICAL TRAY. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG (Bingen Am Rhein, DE). The FDA issued a Cleared decision on December 20, 2016, 294 days after receiving the submission on March 1, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K160574 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2016 |
| Decision Date | December 20, 2016 |
| Days to Decision | 294 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 |