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EsoFLIP® ES-310 Balloon Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172128
510(k) Type
Traditional
Applicant
Crospon Ltd.
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
11/22/2017
Days to Decision
131 days
Submission Type
Summary

EsoFLIP® ES-310 Balloon Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172128
510(k) Type
Traditional
Applicant
Crospon Ltd.
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
11/22/2017
Days to Decision
131 days
Submission Type
Summary