QSW · Class II · 21 CFR 876.4410

FDA Product Code QSW: Endoscopic Traction Device

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.

Leading manufacturers include Covidien, LLC and Micro-Tech (Nanjing) Co., Ltd..

2
Total
1
Cleared
105d
Avg days
2022
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Endoscopic Traction Device Devices (Product Code QSW)

2 devices
1–2 of 2
Cleared Oct 03, 2022
Elastic Traction System
K222354
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 60d
Not Cleared Jun 13, 2022
ProdiGI
DEN220006
Covidien, LLC
Gastroenterology & Urology · 150d

About Product Code QSW - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QSW since 2022, with 1 receiving FDA clearance (average review time: 105 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.

QSW devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →