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510(k) DEN160014

remOVE System by Ovesco Endoscopy AG — Product Code QAG

DEN160014 is an FDA 510(k) premarket notification submitted by Ovesco Endoscopy AG for the device "remOVE System". The FDA issued a decision of De Novo Granted on December 22, 2017. The device falls under product code QAG (Endoscopic Electrosurgical Clip Cutting System), a Class II device regulated under 21 CFR 876.4310. Ovesco Endoscopy AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
December 22, 2017
Date Received
April 11, 2016
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Electrosurgical Clip Cutting System
Device Class
Class II
Regulation Number
876.4310
Review Panel
GU
Submission Type

To fragment metallic clips and remove them from the digestive tract.

Other clearances by Ovesco Endoscopy AG

  • K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n) (December 18, 2025)
  • K242586 — ArgoCap (200.52) (May 22, 2025)
  • K241858 — BARS Set (100.60) (August 26, 2024)
  • K221385 — LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) (August 11, 2022)
  • K200684 — gastroduodenal FTRD Set (June 2, 2020)
  • K183309 — stentfix OTSC System Set (October 22, 2019)
  • K170867 — FTRD System Set (July 25, 2017)
  • K153550 — FTRD System Set (October 12, 2016)
  • K150067 — OTSC Proctology (September 16, 2015)
  • K141790 — AQANIFE (March 6, 2015)

FDA data resources