QSW
- Product code
- QSW
- Device name
- Endoscopic Traction Device
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.4410
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
FDA classification 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.
Official FDA classification page: QSW
Classification and pathway per current FDA publications. Data from openFDA (CC0).