The following data is part of a premarket notification filed by Rigicon Inc. with the FDA for Rigi10 Malleable Penile Prosthesis.
| Device ID | K181673 |
| 510k Number | K181673 |
| Device Name: | Rigi10 Malleable Penile Prosthesis |
| Classification | Prosthesis, Penile |
| Applicant | Rigicon Inc. 150 Motor Pkwy S401 Hauppauge, NY 11788 |
| Contact | Ahmet Melih Luleci |
| Correspondent | Ahmet Melih Luleci Rigicon Inc. 150 Motor Pkwy S401 Hauppauge, NY 11788 |
| Product Code | FAE |
| CFR Regulation Number | 876.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-25 |
| Decision Date | 2019-04-15 |