ONY · Class II · 21 CFR 876.5981

FDA Product Code ONY: Oral Removable Retainer For Weight Management

A Removable Oral Device Used During Meals To Limit Food Intake.

Leading manufacturers include Scientific Intake.

2
Total
1
Cleared
226d
Avg days
2016
Since

FDA 510(k) Cleared Oral Removable Retainer For Weight Management Devices (Product Code ONY)

2 devices
1–2 of 2
Cleared May 18, 2017
SmartByte Device
K171165
Scientific Intake
Gastroenterology & Urology · 28d
Not Cleared Sep 26, 2016
Sensor Monitored Alimentary Restriction Therapy (SMART) Device
DEN150033
Scientific Intake
Gastroenterology & Urology · 423d

About Product Code ONY - Regulatory Context