# K103508: Unmiax Laparoscopic Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Unimax Medical Systems, Inc.
- Decided: Dec 20, 2011 after 386 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: 5 generations back to K932832 (1994). 19 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081503: Aed Monopolar Lap Accessories, National Advanced Endoscopy Devices, Inc. (2008) Summary page 1.

## Most influential descendants
- K142208: Monopolar Laparascopic Accessories (2015), 1 descendant of its own
- K230621: LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes (2023), 0 descendants of its own
- K230650: Monopolar Electrode Surgical Instrument (2023), 0 descendants of its own
- K192235: AEON Laparoscopic Instruments (2019), 0 descendants of its own
- K142868: 5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin (2014), 0 descendants of its own

## Indications for use
The Unimax Laparoscopic Instrument 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/K103508
Methodology: https://510kreport.com/methodology