# K172537: Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Oct 16, 2017 after 55 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
Longest line of descent: 3 generations back to K902257 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162437: Codman EDS3 CSF External Drainage System, Codman & Shurtleff, Inc. (2016) Summary page 4.

## Indications for use
Use of the CODMAN EDS 3 CSF External Drainage System (EDS 3) is indicated for draining cerebrospinal fluid (CSF) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated. Use the External Drainage System Collection Bag with the CODMAN EDS 3 External Drainage System to measure and collect cerebrospinal fluid (CSF).

Source page: https://510kreport.com/device/K172537
Methodology: https://510kreport.com/methodology