# K162437: Codman EDS3 CSF External Drainage System

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Oct 28, 2016 after 58 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902257 (1990). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061568: Codman Eds 3 CSF External Drainage System, Models 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738, Codman & Shurtleff, Inc. (2006) Summary page 4.

## Most influential descendants
- K172537: Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag (2017), 0 descendants of its own

## Recalls of this device
- Nov 28, 2023 · Class II · Z-0634-2024: Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
- Nov 28, 2023 · Class II · Z-0635-2024: Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
- Jan 12, 2021 · Class II · Z-1143-2021: The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.

## Indications for use
Use of the Codman EDS3 CSF External Drainage System 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.

Source page: https://510kreport.com/device/K162437
Methodology: https://510kreport.com/methodology