Home / 510(k) Clearances / K181127

510(k) K181127

EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control by Interscope, Inc. — Product Code PTE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2019
Date Received
April 30, 2018
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)
  • K170120 — EndoRotor (April 18, 2017)

Other clearances for product code PTE

  • K170120 — EndoRotor (April 18, 2017)