K092682 is an FDA 510(k) clearance for the GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS. 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 December 11, 2009, 101 days after receiving the submission on September 1, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K092682 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2009 |
| Decision Date | December 11, 2009 |
| Days to Decision | 101 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 |