DeviceClearance

Product code ODE— Gastroenterology, Urology

MUSE System

Classification name
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
20
First cleared
Most recent

FDA classification definition

“To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.”

— U.S. Food and Drug Administration, device classification record for product code ODE under 21 CFR 876.1500, via openFDA

Market context for product code ODE

FDA has cleared 20 devices under product code ODE between 2000 and 2024, filed by 5 applicant companies. 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 ODE

Recent clearances under product code ODE

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