K092414 is an FDA 510(k) clearance for the CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on March 10, 2010, 215 days after receiving the submission on August 7, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K092414 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2009 |
| Decision Date | March 10, 2010 |
| Days to Decision | 215 days |
| Submission Type | Abbreviated |
| 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 |