MINNOW PENILE IMPLANT PROTECTOR— 510(k) K904262
Substantially EquivalentRuja-Med Medical Marketing
FDA 510(k) clearance K904262 for MINNOW PENILE IMPLANT PROTECTOR, Substantially Equivalent on 1990-12-13. Applicant: Ruja-Med Medical Marketing. Device class: 2.
Clearance details
- Applicant
- Ruja-Med Medical Marketing
- 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
- Traditional
- Location
- Coral Springs, FL, 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
- K181673 — Rigi10 Malleable Penile Prosthesis
- K090663 — AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
- K082006 — AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
- K040959 — MENTOR GENESIS 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.