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510(k) K172128

EsoFLIP® ES-310 Balloon Catheter by Crospon, Ltd. — Product Code PIE

K172128 is an FDA 510(k) premarket notification submitted by Crospon, Ltd. for the device "EsoFLIP® ES-310 Balloon Catheter". The FDA issued a decision of Substantially Equivalent on November 22, 2017. 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
November 22, 2017
Date Received
July 14, 2017
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)
  • K170833 — EndoFLIP® System with FLIP Topography module (April 17, 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 PIE

  • K142000 — ESOFLIP ES (September 25, 2014)

FDA data resources