Endoscopic Pancreatic Debridement Device
The Endoscopic Pancreatic Debridement Device is a gastroenterological device inserted via an endoscope and placed through a cystogastrostomy fistula into the pancreatic cavity, intended for the removal of necrotic tissue from a walled-off pancreatic necrosis (WOPN) cavity. This minimally invasive approach avoids open surgical debridement. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 876.4330 in the Gastroenterology and Urology specialty. It carries product code QNE and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QNE
- Device Class
- FDA class 2
- Regulation Number
- 876.4330
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN200016 | EndoRotor Device | Dec 23, 2020 | Unknown | Interscope, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.