DeviceClearance

Product code GEA— General, Plastic Surgery

SUCTION SYSTEM

Classification name
Cannula, Surgical, General & Plastic Surgery
Device class
Class 1
Regulation
21 CFR 878.4800
Advisory panel
General, Plastic Surgery
Total cleared
36
First cleared
Most recent

Market context for product code GEA

FDA has cleared 36 devices under product code GEA between 1981 and 2001, filed by 30 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code GEA

Adverse events under product code GEA

product code GEA
Malfunction
587
Total
587

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 GEA

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