QNE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Endoscopic Pancreatic Debridement Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4330
- Medical specialty
- Gastroenterology, Urology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| EndoRotor Device (DEN200016) | Interscope, Inc. | 2020-12-23 |
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