# K132931: Apollo System

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Jan 17, 2014 after 121 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- 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 K983365 (1998). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983365: Aesculap Minop System, Aesculap, Inc. (1998) Summary page 1.
- K122756: Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max Canister/Tubing, Penumbra, Inc. (2012) Summary page 1.

## Most influential descendants
- K152699: Apollo System (2016), 4 descendants of its own
- K171332: Artemis Neuro Evacuation Device (2017), 2 descendants of its own
- K201308: Axonpen, Axonmonitor, Axonbox, Tablet (2020), 1 descendant of its own
- K230125: Neuroblade System (2023), 0 descendants of its own
- K181731: MR Compatible Aspiration Kit (2018), 0 descendants of its own

## Indications for use
The ApolloTM System is used for the controlled aspiration of tissue and/or fluids during surgery of the Ventricular System. The ApolloTM disposable wand is inserted through the working channel of a neuroendoscopic trocar.

Source page: https://510kreport.com/device/K132931
Methodology: https://510kreport.com/methodology