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510(k) K170833

EndoFLIP® System with FLIP Topography module by Crospon, Ltd. — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2017
Date Received
March 20, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Gastrointestinal Motility (Electrical)
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

Other clearances by Crospon, Ltd.

  • K183072 — EndoFLIP System (February 15, 2019)
  • K172128 — EsoFLIP® ES-310 Balloon Catheter (November 22, 2017)
  • K160725 — EndoFLIP (May 1, 2016)
  • K142000 — ESOFLIP ES (September 25, 2014)
  • K132337 — ESOFLIP BALLOON DILATION CATHETER (October 7, 2013)
  • K130906 — ENDOFLIP CATHETER (July 17, 2013)
  • K120997 — BAROSTAT SOFTWARE OPTION (August 27, 2012)
  • K110531 — ENDOFLIP ECD (October 6, 2011)
  • K110529 — ENDOFLIP GASTRIC TUBE (July 22, 2011)
  • K102214 — ENDO FLIP (December 16, 2010)

Other clearances for product code FFX

  • K252605 — mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) (December 5, 2025)
  • K240007 — Solar Compact (G4-1) (May 6, 2024)
  • K231861 — EndoflipTM 300 System (July 21, 2023)
  • K223705 — EndoflipTM 300 (April 14, 2023)
  • K222000 — Transit-Pellets (January 18, 2023)
  • K201106 — IntraMarX 3D Radiopaque Marker (May 21, 2020)
  • K191087 — IntraMarX Radiopaque Markers (December 18, 2019)
  • K190208 — Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe (October 3, 2019)
  • K181760 — Transit-Pellets (August 8, 2019)
  • K183072 — EndoFLIP System (February 15, 2019)