QNE — Endoscopic Pancreatic Debridement Device Class II
FDA product code QNE covers "Endoscopic Pancreatic Debridement Device", a Class II medical device regulated under 21 CFR 876.4330. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QNE
- Device Class
- Class II
- Regulation Number
- 876.4330
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN200016 | interscope | EndoRotor Device | December 23, 2020 |