K102122 is an FDA 510(k) clearance for the SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Smith & Nephew, Inc. (Mansfield, US). The FDA issued a Cleared decision on November 22, 2010, 116 days after receiving the submission on July 29, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K102122 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2010 |
| Decision Date | November 22, 2010 |
| Days to Decision | 116 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 |