Home / 510(k) Clearances / K160725

510(k) K160725

EndoFLIP by Crospon, Ltd. — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2016
Date Received
March 16, 2016
Clearance Type
Traditional
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)
  • K170833 — EndoFLIP® System with FLIP Topography module (April 17, 2017)
  • 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)