FLEXI-FLATE PENILE IMPLANT— 510(k) K834347
Substantially EquivalentSurgitek
FDA 510(k) clearance K834347 for FLEXI-FLATE PENILE IMPLANT, Substantially Equivalent on 1984-04-02. Applicant: Surgitek. Device class: 2.
Clearance details
- Applicant
- Surgitek
- 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
- Walker, MI, 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 Surgitek
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.