Class Class II

Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D (K223295)

K223295 2023-01-11 Special
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Description

Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D by Fujifilm Corporaton — FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK223295
Clearance Date2023-01-11
Clearance TypeSpecial
Product CodeFDA
Regulation Number876.1500

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