OAJ

Catheter, Drainage, Intraoral/Extraoral

Product code

OAJ

Device name

Catheter, Drainage, Intraoral/Extraoral

Device class

Class 1

21 CFR

21 CFR 878.4200

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

To allow continuous drainage of saliva and/or fluid irrigation of the salivary duct as well as assisting in maintaining duct patency during the healing process following removal of salivary gland stones for temporary insertion into the salivary gland, whether orally or through the cheek following endoscopic or surgical removal of salivary gland stones

Definition text from the FDA device classification database (U.S. federal government work, public domain).