Saturday - June 13, 2026
HHS FDA Establishes Special Controls for Endoscopic Gastric Suturing Devices
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 . . .

Targeted News Service Document Request Form

This document is available to you by e-mail if you complete the form below with relevant information. There may be a fee for this article or ongoing service of similar materials. We will be in touch shortly.

Name:
What's your
Affiliation
Government Newspaper / Media Business
Public Policy Individual / Student Educators
Email:
Phone:
Organization, if any:
State/Country you are in:
Additonal questions
or comments:

Click here for more information about our products

Click here for more information about our products