K120117 is an FDA 510(k) clearance for the CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on April 16, 2012, 90 days after receiving the submission on January 17, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K120117 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2012 |
| Decision Date | April 16, 2012 |
| Days to Decision | 90 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 |