Last synced on 21 June 2024 at 11:04 pm

Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223295
510(k) Type
Special
Applicant
FUJIFILM Corporaton
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
1/11/2023
Days to Decision
77 days
Submission Type
Summary

Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223295
510(k) Type
Special
Applicant
FUJIFILM Corporaton
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
1/11/2023
Days to Decision
77 days
Submission Type
Summary