# K190168: Aquas Probes

- Pathway: 510(k) (Special)
- Applicant: Genicon, Inc.
- Decided: Mar 14, 2019 after 42 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K935270 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052141: Stryker Stiletto Electrosurgical Probe, Stryker Endoscopy (2005) Summary page 4.
- K062047: Adaptable Monopolar Adaptable and/or Retractable Electrodes, PAJUNK GmbH Medizintechnologie (2006) Summary page 4.

## Indications for use
The GENICON Aquas Probes are instruments insulated for optional monopolar coagulation which enable a surgeon to grasp, manipulate, dissect, retrieve, biopsy, cut or coagulate internal tissue or organs while performing laparoscopic procedures.

Source page: https://510kreport.com/device/K190168
Methodology: https://510kreport.com/methodology