FDA Product Code LYK: Angioscope
Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Vena Medical Holdings Corp and Baxter Healthcare Corp.
41
Total
41
Cleared
155d
Avg days
1983
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
Review times improving: avg
85d
recently vs 159d historically
FDA 510(k) Cleared Angioscope Devices (Product Code LYK)
41 devices
Cleared
Jan 28, 2026
Vena MicroAngioscope™ System
Vena Medical Holdings Corp
Cardiovascular
57d
Cleared
Oct 01, 2025
Vena MicroAngioscope™ System
Vena Medical Holdings Corp
Cardiovascular
113d
Cleared
Apr 17, 2002
KSEA FIBERSCOPE
KARL STORZ Endoscopy-America, Inc.
Cardiovascular
313d
Cleared
Nov 08, 2001
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
Smith & Nephew, Inc.
Cardiovascular
86d
Cleared
Oct 30, 2000
KSEA VASCULAR FIBERSCOPES
KARL STORZ Endoscopy-America, Inc.
Cardiovascular
179d
Cleared
Oct 18, 1993
BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE
Baxter Healthcare Corp
Cardiovascular
208d
Cleared
Jun 21, 1991
4.5F IMAGECATH ANGIOSCOPE
Baxter Healthcare Corp
Cardiovascular
220d
About Product Code LYK - Regulatory Context
510(k) Submission Activity
41 total 510(k) submissions under product code LYK since 1983, with 41 receiving FDA clearance (average review time: 155 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - LYK Product Code
Recent submissions under LYK have taken an average of 85 days to reach a decision - down from 159 days historically, suggesting improved FDA processing for this classification.
LYK devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →