510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223295Substantially Equivalent

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

Fujifilm Corporaton, Ashigara Kami-Gun, JP / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223295 is the FDA 510(k) clearance record for Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D, a class II device, cleared for Fujifilm Corporaton on under FDA product code FDA (Enteroscope And Accessories). FDA's definition for product code FDA reads: "To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k)...". FDA records list 6 510(k) clearances for Fujifilm Corporaton, from to . As of , FDA records show no recalls naming K223295.

Clearance record

Decision date
Received
(77 days to decision)
Product code
FDA Enteroscope And Accessories
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fujifilm Corporaton 798 Miyanodai Kaisei-Machi, Ashigara Kami-Gun, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FDA

Trailing 12 months
1 clearance under product code FDA in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FDA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260