510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233321Substantially Equivalent

Double Balloon Endoscope EN-840T, Over-tube TS-1214C

FUJIFILM Healthcare Americas Corporation, Lexington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233321 is the FDA 510(k) clearance record for Double Balloon Endoscope EN-840T, Over-tube TS-1214C, a class II device, cleared for FUJIFILM Healthcare Americas Corporation 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 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K233321.

Clearance record

Decision date
Received
(258 days to decision)
Product code
FDA Enteroscope And Accessories
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
FUJIFILM Healthcare Americas Corporation 81 Hartwell Ave., Lexington MA
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