Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

FDA product code ODE · 15 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.1500
Review panel
GU
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2000-03-20 – 2024-06-21

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

↑