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510(k) K142000

ESOFLIP ES by Crospon, Ltd. — Product Code PIE

K142000 is an FDA 510(k) premarket notification submitted by Crospon, Ltd. for the device "ESOFLIP ES". The FDA issued a decision of Substantially Equivalent on September 25, 2014. The device falls under product code PIE (Esophageal Dilator With Balloon And Electrode Sensors), a Class II device regulated under 21 CFR 876.5980. Crospon, Ltd. has at least 10 other 510(k) clearances on record.

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)

FDA data resources