# K190174: Miethke Shunt System GAV 2.0 and SA 2.0 Valves

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jul 5, 2019 after 154 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011030 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 4.

## Indications for use
The Miethke Shunt System GAV 2.0 and SA 2.0 are used for cerebrospinal fluid (CSF) shunting.

Source page: https://510kreport.com/device/K190174
Methodology: https://510kreport.com/methodology