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510(k) K132337

ESOFLIP BALLOON DILATION CATHETER by Crospon, Ltd. — Product Code PID

K132337 is an FDA 510(k) premarket notification submitted by Crospon, Ltd. for the device "ESOFLIP BALLOON DILATION CATHETER". The FDA issued a decision of Substantially Equivalent on October 7, 2013. The device falls under product code PID (Esophageal Dilator Balloon With Or Without 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
October 7, 2013
Date Received
July 26, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Esophageal Dilator Balloon With Or Without Electrode Sensors
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

To dilate the lower esophageal sphincter of patients with Achalasia.

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)
  • K142000 — ESOFLIP ES (September 25, 2014)
  • 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 PID

  • K182895 — Wilson-Cook Achalasia Balloon (January 25, 2019)
  • K050232 — RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR (March 11, 2005)

FDA data resources