K181673 is an FDA 510(k) clearance for the Rigi10 Malleable Penile Prosthesis. This device is classified as a Prosthesis, Penile (Class II - Special Controls, product code FAE).
Submitted by Rigicon, Inc. (Hauppauge, US). The FDA issued a Cleared decision on April 15, 2019, 294 days after receiving the submission on June 25, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.3630.
| 510(k) Number | K181673 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2018 |
| Decision Date | April 15, 2019 |
| Days to Decision | 294 days |
| Submission Type | Abbreviated |
| 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 |