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

Angioscope

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

LYK is the FDA product code for Angioscope, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 41 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LYK
Device name
Angioscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
41
Ingested recalls
0

Clearances, product code LYK

By decision year
41 clearances under product code LYK with a decision year between 1983 and 2026, 1990 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code LYK by decision year
YearClearances
19832
19842
19861
19882
19891
19907
19915
19922
19936
19942
19953
19971
20001
20011
20021
20051
20061
20251
20261

Applicants with the most clearances

Product code LYK
Applicants holding the most 510(k) clearances under product code LYK
ApplicantClearances
American Edwards Laboratories3
Applied Medical Resources Corp3
Intertherapy, Inc.3
Advanced Cardiovascular Systems, Inc.2
Angiolaz, Inc.2
Baxter Edwards2
Baxter Healthcare Corporation2
Cardio-Optics, Inc.2
Endovascular, Inc.2
Intramed Laboratories, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code