# K032817: External Drainage Set

- Pathway: 510(k) (Special)
- Applicant: Integra Neurosciences Implants S.A.
- Decided: Oct 6, 2003 after 26 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910853 (1991). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910853: Graduated Cylinder of External Drainage Set, Cordis Corp. (1991) Summary page 1.

## Most influential descendants
- 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
- K150898: LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm (2015), 0 descendants of its own

## Recalls of this device
- Aug 23, 2016 · Class II · Z-2910-2016: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

## Indications for use
The drainage sets are intended for cerebrospinal fluid (CSF) drainage, sampling and collection.

Source page: https://510kreport.com/device/K032817
Methodology: https://510kreport.com/methodology