Endoscopic Traction Device
The Endoscopic Traction Device is a prescription device that is endoscopically applied to retract and elevate gastrointestinal tissue during endoscopic dissection procedures, improving visualization of the dissection plane and assisting with tissue resection, exposure, and removal during procedures such as endoscopic submucosal dissection. Classified as FDA Class 2 under regulation 876.4410, it requires 510(k) clearance and falls under the Gastroenterology and Urology specialty. The device is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QSW
- Device Class
- FDA class 2
- Regulation Number
- 876.4410
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.