# K051831: Gemini Surgical Control & Display System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Surgical, LLC
- Decided: Sep 7, 2005 after 63 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
No predicates in its family tree.
13 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K053510: IR Wireless Foot Switch (2006), 12 descendants of its own
- K083161: Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100) (2009), 9 descendants of its own
- K100638: Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214 (2010), 8 descendants of its own
- K152777: Bovie Disposable Bipolar Ablator (2016), 3 descendants of its own
- K161558: Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating,  Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating (2016), 2 descendants of its own

## Indications for use
The Gemini Surgical Control & Display System is indicated for use in any surgical procedure where single or multiple electrosurgical (unipolar, bipolar, harmonic scalpel, etc.) devices that operate with a foot control are used. The Gemini Surgical Control & Display System integrates the electrosurgical devices into a central system that uses a single Master Foot Control to activate the devices. The SurgiClear smoke evacuation activation unit is indicated for use during laparoscopic cases to automatically remove the smoke/steam/debris resulting from the use of electrosurgical instruments. The system is intended for use in hospitals or outpatient clinics.

Source page: https://510kreport.com/device/K051831
Methodology: https://510kreport.com/methodology