DeviceClearance

Product code OAJ— General, Plastic Surgery

SIALO DRAIN

Classification name
Catheter, Drainage, Intraoral/Extraoral
Device class
Class 1
Regulation
21 CFR 878.4200
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

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”

— U.S. Food and Drug Administration, device classification record for product code OAJ under 21 CFR 878.4200, via openFDA

Market context for product code OAJ

FDA has cleared 1 device under product code OAJ, all in 2008, filed by 1 applicant company. 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.

Top applicants under product code OAJ

Recent clearances under product code OAJ

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