QSW — Endoscopic Traction Device Class II
FDA product code QSW covers "Endoscopic Traction Device", a Class II medical device regulated under 21 CFR 876.4410. Submissions are reviewed by the Gastroenterology, Urology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QSW
- Device Class
- Class II
- Regulation Number
- 876.4410
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.