Rigi10 Malleable Penile Prosthesis— 510(k) K181673
Substantially EquivalentRigicon, Inc.
FDA 510(k) clearance K181673 for Rigi10 Malleable Penile Prosthesis, Substantially Equivalent on 2019-04-15. Applicant: Rigicon, Inc.. Device class: 2.
Clearance details
- Applicant
- Rigicon, Inc.
- Product code
- Code FAE
- Device class
- Class 2
- Regulation
- 21 CFR 876.3630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Hauppauge, NY, US
Recent devices under product code FAE
view all- K183619 — Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
- K090663 — AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
- K082006 — AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
- K040959 — MENTOR GENESIS PENILE PROSTHESIS
- K963328 — AMS AMBICOR PENILE PROSTHESIS
Adverse events under product code FAE
product code FAE- Injury
- 995
- Total
- 995
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.