510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K040048Substantially Equivalent

Fujinon Double Balloon Enteroscopy System

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

K040048 is the FDA 510(k) clearance record for FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM, a class II device, cleared for Fujinon, Inc. 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 K040048.

Clearance record

Decision date
Received
(147 days to decision)
Product code
FDA Enteroscope And Accessories
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fujinon, Inc. P.O. Box 2156, Huntington CT
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 November 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FDA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260