DeviceClearance

Product code QSW— Gastroenterology, Urology

Elastic Traction System

Classification name
Endoscopic Traction Device
Device class
Class 2
Regulation
21 CFR 876.4410
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QSW under 21 CFR 876.4410, via openFDA

Market context for product code QSW

FDA has cleared 2 devices under product code QSW, all in 2022, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QSW

Recent clearances under product code QSW

Data sourced from openFDA. This site is unofficial and independent of the FDA.