510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K895538Substantially Equivalent

Angioscope W/the Optiscope-2 Integrated Angioscopy

Trimedyne, Inc., Tustin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895538 is the FDA 510(k) clearance record for ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY, a class II device, cleared for Trimedyne, Inc. on under FDA product code LYK (Angioscope). FDA records list 58 510(k) clearances for Trimedyne, Inc., from to . As of , FDA records show no recalls naming K895538.

Clearance record

Decision date
Received
(225 days to decision)
Product code
LYK Angioscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Trimedyne, Inc. 1311 Valencia Ave., Tustin CA
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