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510(k) DEN200016

EndoRotor Device by Interscope, Inc. — Product Code QNE

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.

Other clearances by Interscope, Inc.

  • K190715 — EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter (December 13, 2019)
  • K181127 — EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filte (January 3, 2019)
  • K170120 — EndoRotor (April 18, 2017)