510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K860858Substantially Equivalent

Olympus Pf-18 & Pf-25 Ultrathin Angioscope

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

K860858 is the FDA 510(k) clearance record for OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE, 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 no recalls naming K860858.

Clearance record

Decision date
Received
(258 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