510(k) DEN220006
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 13, 2022
- Date Received
- January 14, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Traction Device
- Device Class
- Class II
- Regulation Number
- 876.4410
- Review Panel
- GU
- Submission Type
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.