# K192235: AEON Laparoscopic Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Lexington Medical, Inc.
- Decided: Oct 11, 2019 after 53 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: 6 generations back to K932832 (1994). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103508: Unmiax Laparoscopic Instrument, Unimax Medical Systems, Inc. (2011) Summary page 4.

## Indications for use
AEON™ Laparoscopic Instruments is a family of instruments which includes forceps, scissors, and probes which are intended to be used in general laparoscopic surgical procedures requiring the use of monopolar electrosurgical cutting and/or coagulation.

Source page: https://510kreport.com/device/K192235
Methodology: https://510kreport.com/methodology