510(k) DEN220006
DEN220006 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "ProdiGI". The FDA issued a decision of De Novo Granted on June 13, 2022. The device falls under product code QSW (Endoscopic Traction Device), a Class II device regulated under 21 CFR 876.4410. Covidien, LLC has at least 10 other 510(k) clearances on record.
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.