21 CFR 876.4410 — Endoscopic Traction Device

Gastroenterology, Urology (GU) · Subpart E—Surgical Devices · § 876.4410

Identification

An endoscopic traction device is a prescription device that is endoscopically applied to retract tissue in the gastrointestinal tract during dissection procedures to increase visualization of the dissection plane and assist in tissue resection, exposure, and removal. The ProdiGI system includes a Traction Wire (indicated for esophagus, stomach, and colon) and a Traction Magnet (indicated for stomach and colon) for use in adults during Endoscopic Submucosal Dissection (ESD) procedures.

Classification Rationale

Class II (special controls). The device is classified as Class II because general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, and there is sufficient information to establish special controls to mitigate the risks to health.

Product Codes