510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911278Substantially Equivalent

Olympus Af Angioscope System

Olympus Corp., Lake Success NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911278 is the FDA 510(k) clearance record for OLYMPUS AF ANGIOSCOPE SYSTEM, a class II device, cleared for Olympus Corp. on under FDA product code LYK (Angioscope). FDA records list 149 510(k) clearances for Olympus Corp., from to . As of , FDA records show one recall naming K911278.

Clearance record

Decision date
Received
(114 days to decision)
Product code
LYK Angioscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Corp. 4 Nevada Dr., Lake Success NY
Third party review
No

Clearances, product code LYK

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