DeviceClearance

Product code PCB— Neurology

Duet External Drainage and Monitoring System (EDMS)

Classification name
External Cerebrospinal Fluid (Csf) Diversion
Device class
Class 2
Regulation
21 CFR 882.5560
Advisory panel
Neurology
Total cleared
2
First cleared
Most recent

FDA classification definition

“Cerebrospinal fluid (CSF) diversion intended to alter spinal cord perfusion.”

— U.S. Food and Drug Administration, device classification record for product code PCB under 21 CFR 882.5560, via openFDA

Market context for product code PCB

FDA has cleared 2 devices under product code PCB between 2014 and 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PCB

Adverse events under product code PCB

product code PCB
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code PCB

Data sourced from openFDA. This site is unofficial and independent of the FDA.