QSW

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Endoscopic Traction Device

Device class

Class II (moderate risk)

Regulation

21 CFR 876.4410

Medical specialty

Gastroenterology, Urology

FDA definition

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.

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