MENTOR GENESIS PENILE PROSTHESIS— 510(k) K040959
Substantially EquivalentMentor Corp.
FDA 510(k) clearance K040959 for MENTOR GENESIS PENILE PROSTHESIS, Substantially Equivalent on 2004-10-29. Applicant: Mentor Corp.. Device class: 2.
Clearance details
- Applicant
- Mentor Corp.
- 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
- Santa Barbara, CA, US
Recent devices under product code FAE
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- K181673 — Rigi10 Malleable Penile Prosthesis
- K090663 — AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
- K082006 — AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
- K963328 — AMS AMBICOR PENILE PROSTHESIS
More clearances from Mentor Corp.
view allAdverse 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 →
Recalls naming K040959
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040959.
Data sourced from openFDA. This site is unofficial and independent of the FDA.