K140576 is an FDA 510(k) clearance for the Y WIRE 2. This device is classified as a Passer, Wire, Orthopedic (Class I - General Controls, product code HXI).
Submitted by Safewire, LLC (Holland, US). The FDA issued a Cleared decision on May 20, 2014, 75 days after receiving the submission on March 6, 2014.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K140576 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2014 |
| Decision Date | May 20, 2014 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HXI — Passer, Wire, Orthopedic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |