Endoscopic Traction Device
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Jiangsu.
- Micro-Tech (Nanjing) Co., Ltd. Jiangsu, contract manufacturer
What Is It?
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.
What Is FDA Product Code QSW?
Endoscopic Traction Device is FDA product code QSW, Class 2, 21 CFR 876.4410.
What Does It Take to Sell It in the United States?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 60 days from receipt to decision.