QSW — Endoscopic Traction Device Class II

FDA Device Classification

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K222354micro-tech (nanjing) coElastic Traction SystemOctober 3, 2022
DEN220006covidienProdiGIJune 13, 2022