PCB · Class II · 21 CFR 882.5560

FDA Product Code PCB: External Cerebrospinal Fluid (csf) Diversion

Cerebrospinal Fluid (csf) Diversion Intended To Alter Spinal Cord Perfusion.

Leading manufacturers include Medtronic Neurosurgery.

2
Total
1
Cleared
357d
Avg days
2014
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 105d recently vs 609d historically

FDA 510(k) Cleared External Cerebrospinal Fluid (csf) Diversion Devices (Product Code PCB)

2 devices
1–2 of 2
Cleared Oct 24, 2024
Duet External Drainage and Monitoring System (EDMS)
K242034
Medtronic Neurosurgery
Neurology · 105d

About Product Code PCB - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code PCB since 2014, with 1 receiving FDA clearance (average review time: 357 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under PCB have taken an average of 105 days to reach a decision - down from 609 days historically, suggesting improved FDA processing for this classification.

PCB devices are reviewed by the Neurology panel. Browse all Neurology devices →