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

Updated on : 01-06-2026

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. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.This order is effective 28 May 2026. The classification was applicable on 12 July 2022.91 Federal Register (FR) 31660, 28 May 2026; Title 21 Code of Federal Regulations (CFR) Part 876

https://www.govinfo.gov/content/pkg/FR-2026-05-28/html/2026-10621.htm

https://www.govinfo.gov/content/pkg/FR-2026-05-28/pdf/2026-10621.pdfThis final amendment; final order is identified by Docket Number FDA-2026-N-5200. The Docket Folder is available from Regulations.gov at https://www.regulations.gov/docket/FDA-2026-N-5200/document and provides access to primary documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. The earlier final order notified as G/TBT/N/USA/1414 is identified by Docket Number FDA–2018–N–1862
 

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

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