510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100584Substantially Equivalent

Evis Exeraii 180 System

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

K100584 is the FDA 510(k) clearance record for EVIS EXERAII 180 SYSTEM, a class II device, cleared for Olympus Medical Systems Corporation on under FDA product code NWB (Endoscope, Accessories, Narrow Band Spectrum). FDA's definition for product code NWB reads: "Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract". FDA records list 186 510(k) clearances for Olympus Medical Systems Corporation, from to . As of , FDA records show 9 recalls naming K100584.

Clearance record

Decision date
Received
(122 days to decision)
Product code
NWB Endoscope, Accessories, Narrow Band Spectrum
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Medical Systems Corporation Regulatory Affairs & Quality, Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NWB

Trailing 12 months

FDA records hold no clearances under product code NWB in the trailing twelve months.

FDA records show no clearances under product code NWB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NWB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260