K140064 is an FDA 510(k) clearance for the SURGISLEEVE WOUND PROTECTOR. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on March 12, 2014, 61 days after receiving the submission on January 10, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K140064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 2014 |
| Decision Date | March 12, 2014 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |