# K081503: Aed Monopolar Lap Accessories

- Pathway: 510(k) (Traditional)
- Applicant: National Advanced Endoscopy Devices, Inc.
- Decided: Sep 25, 2008 after 119 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 K932832 (1994). 18 ancestors in all.
7 later devices descend from it; 1 cites 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)
- K052759: Dan Monopolar Lap Accessories, Dannoritzer Medizintechnik GmbH & Co. KG (2006) Summary page 1.
- K024286: Gyrus Open Forceps, Gyrus Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- K103508: Unmiax Laparoscopic Instrument (2011), 6 descendants of its own
- 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

## Indications for use
AED Monopolar Lap Accessories are reusable devices'(forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.

Source page: https://510kreport.com/device/K081503
Methodology: https://510kreport.com/methodology