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510(k) K170120

EndoRotor by Interscope, Inc. — Product Code PTE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2017
Date Received
January 13, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Morcellator Gastroenterology
Device Class
Class II
Regulation Number
884.1690
Review Panel
GU
Submission Type

For use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection)

Other clearances by Interscope, Inc.

  • DEN200016 — EndoRotor Device (December 23, 2020)
  • 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)

Other clearances for product code PTE

  • K181127 — EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filte (January 3, 2019)