K120474 is an FDA 510(k) clearance for the GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on July 10, 2012, 145 days after receiving the submission on February 16, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K120474 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 2012 |
| Decision Date | July 10, 2012 |
| Days to Decision | 145 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 |