# K172022: CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Oct 3, 2017 after 90 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: 6 generations back to K944222 (1995). 13 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944222: Codman-Medos Valve Shunt System, Johnson & Johnson Professionals, Inc. (1995) Summary page 4.
- K973774: Codman Hakim Micro Precision Valve, Johnson & Johnson Professionals, Inc. (1997) Summary page 4.
- K974739: Hakim Programmable Valve System, Johnson & Johnson Professionals, Inc. (1998) Summary page 4.
- K980778: Hakim Micro Programmable Valve System, Johnson & Johnson Professionals, Inc. (1998) Summary page 4.
- K992173: Siphonguard CSF Control Device, Johnson & Johnson Professionals, Inc. (2000) Summary page 4.
- K020667: Codman Hakim Shunt Systems, Codman & Shurtleff, Inc. (2002) Summary page 4.
- K041296: Modification to Hakim Precision Valve System, Hakim Programmable Valve System, Hakim Micro Programmable Valve System, SI, Codman & Shurtleff, Inc. (2004) Summary page 4.
- K053350: Modification to Codman Hakim Shunt Systems, Codman & Shurtleff, Inc. (2006) Summary page 4.
- K102589: Codman Bactiseal Catheters, Codman Bactiseal Evd Catheter, Codman & Shurtleff, Inc. (2011) Summary page 4.
- K122118: Hakim Programmable and Precision Valve Shunt System, Codman & Shurtleff, Inc. (2012) Summary page 4.
- (no number) HOLTER Catheters and UNI-SHUNT System: named in the summary without a submission number

## 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
- K221840: Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves (2022), 0 descendants of its own

## Recalls of this device
- Dec 14, 2020 · Class II · Z-0724-2021: Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa

## Indications for use
The Codman HAKIM Precision Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus. The Codman HAKIM Programmable Valve System is an implantable device that provides constant intraventricular pressure and drainages of cerebral spinal fluid (CSF) for the management of hydrocephalus. The Codman HOLTER Lumboperitoneal (LP) Shunt is indicated for shunting cerebrospinal fluid when the lumbo-peritoneal route is the procedure of choice in the treatment of communicating hydrocephalus. The Codman HOLTER Atrial Catheters are indicated for use to shunt cerebrospinal fluid, when shunting of cerebrospinal fluid to the atrium is the procedure of choice in the treatment of hydrocephalus. The Codman HOLTER Ventricular Catheters are indicated for use to gain access to the ventricles for diagnostic purposes and in the treatment of hydrocephalus. The Codman Medos Ventricular Catheter is indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated. The UNI-SHUNT System is indicated for use as a one-piece ventriculo-peritoneal shunt system for the palliative treatment of hydrocephalus. No other use is recommended. The Codman BACTISEAL Catheters are indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

Source page: https://510kreport.com/device/K172022
Methodology: https://510kreport.com/methodology