FDA Product Code JCX: Apparatus, Suction, Ward Use, Portable, Ac-powered
Leading manufacturers include Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, Microvention and Excitus AS.
FDA 510(k) Cleared Apparatus, Suction, Ward Use, Portable, Ac-powered Devices (Product Code JCX)
About Product Code JCX - Regulatory Context
510(k) Submission Activity
76 total 510(k) submissions under product code JCX since 1977, with 76 receiving FDA clearance (average review time: 96 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for JCX submissions have been consistent, averaging 85 days recently vs 96 days historically.
JCX devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →