WTO notification · TBT
United StatesUpdated: check whether it is now adopted or in force
Official title
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Electrosurgical Clip Cutting System
The United States issued an addendum on 29 May 2026 to the earlier TBT notification G/TBT/N/USA/1414. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 8 November 2018.
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Endoscopic electrosurgical clip cutting system
Latest notice (G/TBT/N/USA/1414/Add.1, 29 May 2026)
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: This final amendment; final order is identified by Docket Number FDA-2026-N-5200. The Docket Folder is available from Regulations.gov at 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.
The Food and Drug Administration (FDA or we) is classifying the endoscopic electrosurgical clip cutting system 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 the endoscopic electrosurgical clip cutting system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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.
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/USA/1414/Add.1
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: This final amendment; final order is identified by Docket Number FDA-2026-N-5200. The Docket Folder is available from Regulations.gov at 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.
Regular notificationG/TBT/N/USA/1414
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Electrosurgical Clip Cutting System
The Food and Drug Administration (FDA or we) is classifying the endoscopic electrosurgical clip cutting system 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 the endoscopic electrosurgical clip cutting system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
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