# K042825: Accudrain External CSF Drainage System

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Dec 21, 2004 after 70 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hermetic Plus External CSF Drainage System: named in the summary without a submission number
- (no number) Integra NeuroSciences External Drainage Set (EDS): named in the summary without a submission number
- (no number) Codman External Drainage System (EDS3): named in the summary without a submission number

## Indications for use
Draining and monitoring of Cerebrospinal Fluid (CSF) flow from the ventricles of the brain or lumbar subarachnoid space is indicated in selected patients to: * Reduce Intracranial Pressure (ICP) * Monitor Intracranial Pressure (ICP) * Monitor Cerebrospinal Fluid (CSF) * Provide temporary CSF drainage

Source page: https://510kreport.com/device/K042825
Methodology: https://510kreport.com/methodology