Home / 510(k) Clearances / K142000

510(k) K142000

ESOFLIP ES by Crospon, Ltd. — Product Code PIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2014
Date Received
July 23, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Esophageal Dilator With Balloon And Electrode Sensors
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

To dilate esophageal strictures with a dilating balloon and electrode sensors.

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)
  • K160725 — EndoFLIP (May 1, 2016)
  • 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 PIE

  • K172128 — EsoFLIP® ES-310 Balloon Catheter (November 22, 2017)