510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222584Substantially Equivalent

Evis X1 Video System Center Olympus Cv-1500, Colonovideoscope Olympus Cf-Hq1100dl/i, Gastrointestinal Videoscope Olympus Gif-1100

Olympus Medical Systems Corp., Tokyo, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222584 is the FDA 510(k) clearance record for EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100, a class II device, cleared for Olympus Medical Systems Corporation on under FDA product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology). FDA's definition for product code FET reads: "To allow for visualization of body cavities through an endoscope by projecting images to a monitor". FDA records list 186 510(k) clearances for Olympus Medical Systems Corporation, from to . As of , FDA records show one recall naming K222584.

Clearance record

Decision date
Received
(243 days to decision)
Product code
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Medical Systems Corporation 2951 Ishikawa-Cho,, Tokyo, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FET

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