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
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Endoscopic Traction Device Devices (Product Code QSW)
2 devices
Cleared
Oct 03, 2022
Elastic Traction System
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology
60d
Not Cleared
Jun 13, 2022
ProdiGI
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 remained relatively stable over the observed period, with 0 submissions in the last 24 months.