Name: Predicase
Price: 199 USD

K-number	K223295
Device name	Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D
Applicant	Fujifilm Corporaton
Product code	FDA
Device class	Class II
Decision date	Jan 11, 2023
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.