DeviceClearance

Product code ONY— Gastroenterology, Urology

Sensor Monitored Alimentary Restriction Therapy (SMART) Device

Classification name
Oral Removable Retainer For Weight Management
Device class
Class 2
Regulation
21 CFR 876.5981
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

FDA classification definition

“A removable oral device used during meals to limit food intake.”

— U.S. Food and Drug Administration, device classification record for product code ONY under 21 CFR 876.5981, via openFDA

Market context for product code ONY

FDA has cleared 2 devices under product code ONY between 2016 and 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code ONY

Recent clearances under product code ONY

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