K161176 is an FDA 510(k) clearance for the ARTOURA Breast Tissue Expanders with Smooth Surface. This device is classified as a Tissue Expander And Accessories.
Submitted by Mentor Worldwide, LLC (Irvin, US). The FDA issued a Cleared decision on May 23, 2016, 27 days after receiving the submission on April 26, 2016.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K161176 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2016 |
| Decision Date | May 23, 2016 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LCJ — Tissue Expander And Accessories |
| Device Class | — |