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U.S. Department of Health and Human Services

Product Classification

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Device angioscope
Regulation Description Endoscope and accessories.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Cardiovascular
Product CodeLYK
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Interventional Cardiology Devices Branch (ICDB)
Submission Type 510(k)
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons