USA - Medical Devices, Gastroenterology-Urology Devices, Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss

​The Food and Drug Administration (FDA) is classifying the endoscopic suturing device for altering gastric anatomy for weight loss into class II (special controls). 

The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the endoscopic suturing device for altering gastric anatomy for weight loss. 

This order is effective May 28, 2026. 

The classification was applicable on July 12, 2022.