K010711 is an FDA 510(k) clearance for the ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Advanced Surgical Concepts (Asc) (North Attleboro, US). The FDA issued a Cleared decision on May 22, 2001, 74 days after receiving the submission on March 9, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K010711 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 2001 |
| Decision Date | May 22, 2001 |
| Days to Decision | 74 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 |