# K181731: MR Compatible Aspiration Kit

- Pathway: 510(k) (Traditional)
- Applicant: Mri Interventions, Inc.
- Decided: Nov 20, 2018 after 144 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: 3 generations back to K853143 (1985). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152699: Apollo System, Penumbra, Inc. (2016) Summary page 4.

## Indications for use
The MR Compatible Aspiration System is used for controlled aspiration of blood, clotted blood, cystic components of tumors, abscess, colloid cysts, and cerebrospinal fluid using a manual syringe during surgery of the Ventricle System or Cerebrum.

Source page: https://510kreport.com/device/K181731
Methodology: https://510kreport.com/methodology