510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K090116Substantially Equivalent

Fujinon Colonoscope for Double Balloon Enterscopy System Model, Ec-450B15

FUJIFILM Healthcare Americas Corporation, Kita- Ku Saitama, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090116 is the FDA 510(k) clearance record for FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15, a class II device, cleared for Fujinon, Inc. on under FDA product code FDF (Colonoscope And Accessories, Flexible/Rigid). FDA's definition for product code FDF reads: "To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807...". FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K090116.

Clearance record

Decision date
Received
(91 days to decision)
Product code
FDF Colonoscope And Accessories, Flexible/Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fujinon, Inc. 1-324 Uetake-Cho, Kita- Ku Saitama, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FDF

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