# K161853: proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Feb 27, 2017 after 236 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: 9 generations back to K944222 (1995). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062009: Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451T, Aesculap, Inc. (2007) Summary page 4.
- K103003: Aesculap- Meithke Progav Programmable Shunt System, Aesculap, Inc. (2010) Summary page 4.
- K141687: Aesculap - Meithke Progav 2.0 Adjustable Shunt System, Aesculap, Inc. (2015) Summary page 8.
- K120559: Aesculap-Meithke Prosa Adjustable Shunt System, Aesculap, Inc. (2012) Summary page 11.

## Most influential descendants
- K192266: M. Blue Adjustable Shunt System (2019), 0 descendants of its own

## Recalls of this device
- Sep 21, 2017 · Class II · Z-0809-2018: A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.

## Indications for use
The Miethke proGAV Programmable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. The Miethke proGAV 2.0 Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. The Miethke proSA Adjustable 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/K161853
Methodology: https://510kreport.com/methodology