K172389 is an FDA 510(k) clearance for the ePTFE-Coated Auricular Implant. This device is classified as a Prosthesis, Ear, Internal (Class II - Special Controls, product code FZD).
Submitted by Implantech Associates, Inc. (Ventura, US). The FDA issued a Cleared decision on July 18, 2018, 344 days after receiving the submission on August 8, 2017.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3590.
| 510(k) Number | K172389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2017 |
| Decision Date | July 18, 2018 |
| Days to Decision | 344 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FZD - Prosthesis, Ear, Internal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3590 |