# K033135: Stryker Wireless Universal Footswitch System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Aug 9, 2004 after 314 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931783 (1993). 12 ancestors in all.
13 later devices descend from it; 4 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)
- K022393: Merdoc System, Stryker Endoscopy (2003) Summary page 1.
- K991960: Serfas, Serfas Generator, Serfas Console, Serfas Probe, Serfas Handpiece Cable, Serfas Footswitch, Stryker Endoscopy (1999) Summary page 1.
- K991703: Stryker Hermes-Ready Total Performance System, Stryker Instruments (1999) Summary page 1.

## 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 Stryker Wireless Universal Footswitch System (SWUFS) is indicated for use with compatible endoscopic and general surgery devices. It will utilize a single footswitch to selectively control multiple devices, which typically each have their own dedicated footswitch. The system includes a wireless footswitch and receiver. The SWUFS will be an accessory to and provide footswitch input control for the Stryker Total Performance System, the SERFAS (Stryker Endoscopy Radio Frequency Ablation System) consoles, and the Valleylab Electrosurgical Generator.

Source page: https://510kreport.com/device/K033135
Methodology: https://510kreport.com/methodology
