# K110206: Aesculap- Meithke Shunt System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Oct 27, 2011 after 275 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 2 (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; 1 cites 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)
- K011030: Aesculap -Miethke Shunt System, Aesculap, Inc. (2002) Summary page 2.
- K042465: PS Medical Strata II Valve, Medtronic Neurosurgery (2004) Summary page 2.

## Most influential descendants
- K120559: Aesculap-Meithke Prosa Adjustable Shunt System (2012), 2 descendants of its own
- K161853: proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System (2017), 1 descendant of its own
- K192266: M. Blue Adjustable Shunt System (2019), 0 descendants of its own

## Recalls of this device
- Nov 11, 2014 · Class III · Z-0814-2015: Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients' labels for the miniNAV (FV660T). There are no patient injuries resulting from this issue.
- Jun 4, 2012 · Class II · Z-0805-2013: The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5 cm mark on the catheter. In some cases the surgeon will want to adjust the deflector to a dif

## Indications for use
The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

Source page: https://510kreport.com/device/K110206
Methodology: https://510kreport.com/methodology