DeviceClearance

Product code GEY— General, Plastic Surgery

150 DRIVER REAMER

Classification name
Motor, Surgical Instrument, Ac-Powered
Device class
Class 1
Regulation
21 CFR 878.4820
Advisory panel
General, Plastic Surgery
Total cleared
41
First cleared
Most recent

Market context for product code GEY

FDA has cleared 41 devices under product code GEY between 1981 and 2005, filed by 28 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

last 15 years

Top applicants under product code GEY

Adverse events under product code GEY

product code GEY
Malfunction
7,488
Total
7,488

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 GEY

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