K031889 is an FDA 510(k) clearance for the ALEXIS WOUND RETRACTOR. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on September 22, 2003, 96 days after receiving the submission on June 18, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K031889 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 2003 |
| Decision Date | September 22, 2003 |
| Days to Decision | 96 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 |