K182335 is an FDA 510(k) clearance for the CPX 4 Breast Tissue Expander 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 September 25, 2018, 28 days after receiving the submission on August 28, 2018.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K182335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2018 |
| Decision Date | September 25, 2018 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LCJ — Tissue Expander And Accessories |
| Device Class | — |