K183619 is an FDA 510(k) clearance for the Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device. This device is classified as a Prosthesis, Penile (Class II - Special Controls, product code FAE).
Submitted by Boston Scientific Corporation (Minnetonka, US). The FDA issued a Cleared decision on April 16, 2019, 111 days after receiving the submission on December 26, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.3630.
| 510(k) Number | K183619 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2018 |
| Decision Date | April 16, 2019 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAE — Prosthesis, Penile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.3630 |