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510(k) K132337

Device
ESOFLIP BALLOON DILATION CATHETER
Applicant
CROSPON, LTD.
510(k) number
K132337
Product code
PID  
Decision
Substantially Equivalent (SESE)
Decision date
2013-10-07
Date received
2013-07-26
Regulation
876.5980
Classification name
Esophageal Dilator Balloon With Or Without Electrode Sensors
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PAUL DRYDEN
Address
24301 Woodsage Dr. Bonita Springs FL US 34134 34134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PID  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K182895Wilson-Cook Achalasia BalloonWilson-Cook Medical, Inc.2019-01-25
K050232RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATORBoston Scientific Corp2005-03-11

Legacy Summary#

summary

FDA Review#

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