K102544 is an FDA 510(k) clearance for the SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY. 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., Endoscopy Div. (Mansfield, US). The FDA issued a Cleared decision on January 5, 2011, 124 days after receiving the submission on September 3, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K102544 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2010 |
| Decision Date | January 05, 2011 |
| Days to Decision | 124 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 |