DeviceClearance

K181673

Substantially Equivalent

Rigi10 Malleable Penile Prosthesis

Applicant
Rigicon, Inc.
Product code
FAE
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Hauppauge, NY, US
Download summary PDF View on FDA.gov ↗

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.