# K110751: Codman Bactiseal Endoscopic Venticular Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: May 9, 2011 after 52 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 K934196 (1994). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934196: Codman Quick Shunt Kit, Cat. #82-6570, Codman & Shurtleff, Inc. (1994) Summary page 1.
- K003322: Codman Bactiseal Catheters, Codman & Shurtleff, Inc. (2001) Summary page 1.

## Most influential descendants
- K233445: Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter (2024), 1 descendant of its own
- K243531: Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (2025), 0 descendants of its own

## Recalls of this device
- Dec 14, 2020 · Class II · Z-0725-2021: Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa

## Indications for use
CODMAN® BACTISEAL® Endoscopic Ventricular Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain.

Source page: https://510kreport.com/device/K110751
Methodology: https://510kreport.com/methodology
