# K912780: Monopolar Laparoscopic Electrodes W/Eletroshield

- Pathway: 510(k) (Traditional)
- Applicant: Electroscope, Inc.
- Decided: Dec 30, 1991 after 189 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K191612: Encision AEM Monopolar Laparoscopic Instruments and Accessories (2020), 1 descendant of its own
- K100711: Suction Irrigation Electrodes and Adapters (2010), 1 descendant of its own
- K201018: Encision AEM enTouch 2X Scissor (2020), 0 descendants of its own
- K131949: Aem Disposable Suction Irrigation Electrodes (2013), 0 descendants of its own

## Recalls of this device
- Apr 7, 2011 · Not classified · Z-2395-2011: Sterility may be compromised due to holes in packaging.
- Apr 7, 2011 · Not classified · Z-2398-2011: Sterility may be compromised due to holes in packaging.
- Apr 7, 2011 · Not classified · Z-2396-2011: Sterility may be compromised due to holes in packaging.
- Apr 7, 2011 · Not classified · Z-2400-2011: Sterility may be compromised due to holes in packaging.
- Apr 7, 2011 · Not classified · Z-2397-2011: Sterility may be compromised due to holes in packaging.
- Apr 7, 2011 · Not classified · Z-2399-2011: Sterility may be compromised due to holes in packaging.
- Jun 11, 2004 · Not classified · Z-1074-04: Electrosurgical tip may break or come off during use.
- Jan 15, 2003 · Not classified · Z-0470-03: Reports of needle fixed-tip electrodes becoming loose or breaking off.

Source page: https://510kreport.com/device/K912780
Methodology: https://510kreport.com/methodology