DeviceClearance

K023898

Substantially Equivalent

GYNE IDEAS MINITAPE RP DEVICE

Applicant
Gyne Ideas , Ltd.
Product code
PAH
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Farfield, CT, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code PAH

product code PAH
Injury
886
Malfunction
529
Total
1,415

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.