HHS FDA Establishes Special Controls for Endoscopic Gastric Suturing Devices
June 02, 2026
June 02, 2026
WASHINGTON, June 2 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final order classifying endoscopic suturing devices used to alter gastric anatomy for weight loss as class II medical devices, a move the agency said will provide reasonable assurance of safety and effectiveness while reducing regulatory burdens for manufacturers.
The action applies to a category of devices that use suturing to approximate gastric tissue and restr . . .
The action applies to a category of devices that use suturing to approximate gastric tissue and restr . . .
