MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE)— 510(k) K890402
Substantially EquivalentMentor Corp.
FDA 510(k) clearance K890402 for MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE), Substantially Equivalent on 1989-08-03. 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
- Goleta, CA, US
Recent devices under product code FAE
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- K090663 — AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
- K082006 — AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
- K040959 — MENTOR GENESIS 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.