# K061568: Codman Eds 3 CSF External Drainage System, Models 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738

- Pathway: 510(k) (Special)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Sep 29, 2006 after 115 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: 1 generation back to K902257 (1990). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902257: Codman* External Drainage System II (Eds-II), Codman & Shurtleff, Inc. (1990) Summary page 1.
- K910938: Codman External Drainage System II (Eds II), Codman & Shurtleff, Inc. (1991) Summary page 1.
- K954021: External Drainage System (Eds and Eds II), Johnson & Johnson Professionals, Inc. (1995) Summary page 1.

## Most influential descendants
- K162437: Codman EDS3 CSF External Drainage System (2016), 1 descendant of its own
- K121248: Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set (2000MM) Safety Cushion for Tubing Set Attac (2013), 1 descendant of its own
- K172537: Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag (2017), 0 descendants of its own
- K150898: LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm (2015), 0 descendants of its own

## Recalls of this device
- Sep 15, 2014 · Class II · Z-0089-2015: tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular
- Sep 15, 2014 · Class II · Z-0090-2015: tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular
- Sep 15, 2014 · Class II · Z-0091-2015: tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular

## Indications for use
Use of the CODMAN EDS 3 CSF External Drainage System is indicated for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics 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/K061568
Methodology: https://510kreport.com/methodology