K113268 is an FDA 510(k) clearance for the ALEXIS O WOUND PROTECTOR/RETRACTOR. This device is classified as a Ring (wound Protector), Drape Retention, Internal (Class II - Special Controls, product code KGW).
Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on February 8, 2013, 462 days after receiving the submission on November 4, 2011.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K113268 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2011 |
| Decision Date | February 08, 2013 |
| Days to Decision | 462 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGW — Ring (wound Protector), Drape Retention, Internal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |