# K100711: Suction Irrigation Electrodes and Adapters

- Pathway: 510(k) (Traditional)
- Applicant: Encision, Inc.
- Decided: Jun 9, 2010 after 89 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934094 (1994). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912780: Monopolar Laparoscopic Electrodes W/Eletroshield, Electroscope, Inc. (1991) Summary page 1.
- K003674: Nezhat-Dorsey Reusable Electrosurgical Attachments: J-Hook Tip, L-Hook Tip, Corbitt Spatula Tip, Needle Tip, Ball Tip, Davol Inc., Sub. C. R. Bard, Inc. (2000) Summary page 1.
- K963765: Stryker Strykeflow Electrocautery Probes, Stryker Endoscopy (1997) Summary page 1.
- K964175: Valleylab E2750 Laparoscopic Handset, Valleylab E2770 Series Electrodes, Valleylab, Inc. (1996) Summary page 1.
- K973890: Universalplus Laparoscopic Abc/Electrosurgical Electrode, Conmedcorp (1998) Summary page 1.

## Most influential descendants
- K131949: Aem Disposable Suction Irrigation Electrodes (2013), 0 descendants of its own

## Recalls of this device
- Aug 24, 2011 · Not classified · Z-3095-2011: Electrode tips have been reported breaking off during use or cleaning.
- Aug 24, 2011 · Not classified · Z-3094-2011: Electrode tips have been reported breaking off during use or cleaning.
- Aug 24, 2011 · Not classified · Z-3096-2011: Electrode tips have been reported breaking off during use or cleaning.
- Aug 24, 2011 · Not classified · Z-3097-2011: Electrode tips have been reported breaking off during use or cleaning.
- Aug 24, 2011 · Not classified · Z-3093-2011: Electrode tips have been reported breaking off during use or cleaning.

## Indications for use
Encision's Suction Irrigation Electrodes and Adapters are intended for evacuation of body fluids and to cut and coagulate tissue through a trocar cannula for various general surgical laparoscopic procedures.

Source page: https://510kreport.com/device/K100711
Methodology: https://510kreport.com/methodology