K140588 is an FDA 510(k) clearance for the FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS. This device is classified as a Hood, Surgical (Class II - Special Controls, product code FXY).
Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on June 26, 2014, 111 days after receiving the submission on March 7, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K140588 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2014 |
| Decision Date | June 26, 2014 |
| Days to Decision | 111 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXY — Hood, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |