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Pathfinder Endoscope Overtube with Balloon Device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230801
510(k) Type
Traditional
Applicant
Neptune Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/28/2023
Days to Decision
127 days
Submission Type
Summary

Pathfinder Endoscope Overtube with Balloon Device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230801
510(k) Type
Traditional
Applicant
Neptune Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/28/2023
Days to Decision
127 days
Submission Type
Summary