510(k) DEN200016
DEN200016 is an FDA 510(k) premarket notification submitted by Interscope, Inc. for the device "EndoRotor Device". The FDA issued a decision of De Novo Granted on December 23, 2020. The device falls under product code QNE (Endoscopic Pancreatic Debridement Device), a Class II device regulated under 21 CFR 876.4330. Interscope, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 23, 2020
- Date Received
- March 16, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Pancreatic Debridement Device
- Device Class
- Class II
- Regulation Number
- 876.4330
- Review Panel
- GU
- Submission Type
An endoscopic pancreatic debridement device is inserted via an endoscope and placed through a cystogastrostomy fistula into the pancreatic cavity. It is intended for removal of necrotic tissue from a walled off pancreatic necrosis (WOPN) cavity.