K142519 is an FDA 510(k) clearance for the InterActive Complete Surgical Tray. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Implant Direct Sybron Manufacturing, LLC (Calabasas, US). The FDA issued a Cleared decision on April 15, 2015, 219 days after receiving the submission on September 8, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K142519 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2014 |
| Decision Date | April 15, 2015 |
| Days to Decision | 219 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 |