DeviceClearance

Product code FAE— Gastroenterology, Urology

AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

Classification name
Prosthesis, Penile
Device class
Class 2
Regulation
21 CFR 876.3630
Advisory panel
Gastroenterology, Urology
Total cleared
32
First cleared
Most recent

Market context for product code FAE

FDA has cleared 32 devices under product code FAE between 1980 and 2019, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code FAE

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 →

Recent clearances under product code FAE

Data sourced from openFDA. This site is unofficial and independent of the FDA.