Federal Register #FDA-2026-N-5149

FDA Classifies Endoscopic Traction Device as Class II Medical Device with Special Controls

This FDA final order establishes a new regulatory classification for endoscopic traction devices: - Government buyer: Food and Drug Administration (FDA), Department of Health and Human Services - Applies to all OEMs and vendors manufacturing endoscopic traction devices - Product/service: Endoscopic traction device - Used endoscopically to retract tissue in the gastrointestinal tract during dissection procedures - Enhances visualization and assists in tissue resection, exposure, and removal - No specific OEMs, vendors, part numbers, or purchase quantities are listed - Unique requirements (special controls): - In vivo and non-clinical performance testing - Usability assessment - Sterility and biocompatibility validation - Shelf life demonstration - Specific labeling requirements - Devices must comply with these controls to avoid automatic Class III classification and must meet premarket notification (510(k)) requirements - This is a regulatory classification notice, not a procurement or award announcement

Description

The Food and Drug Administration (FDA) is classifying the endoscopic traction device into class II (special controls). This classification aims to ensure safety and effectiveness, reduce regulatory burdens, and improve patient access. The device is a prescription device used endoscopically to retract tissue in the gastrointestinal tract during dissection procedures to enhance visualization and assist in tissue resection, exposure, and removal. Special controls include performance testing, usability assessment, sterility, biocompatibility, shelf life, and labeling requirements.

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