# K112621: WIS1000

- Pathway: 510(k) (Abbreviated)
- Applicant: Foreseeson Custom Displays, Inc.
- Decided: May 30, 2012 after 265 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K081995 (2008). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081995: Stryker Vision Elect Whdtv (Stryker VE Whdtv), Stryker Endoscopy (2008) Summary page 1.
- K100195: NDS Surgical Imaging, LLC for the Zerowire Duo Wireless HD Video Transfer System, Model WU-WX-WY (Where U=R or T, W=P, X, Nds Surgical Imaging (2010) Summary page 1.

## Most influential descendants
- K151609: ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2 (2015), 3 descendants of its own
- K161228: Radiance Ultra Series ZeroWire Embedded (2016), 2 descendants of its own
- K222890: Radiance Ultra 32 4K Zerowire Duo (2022), 0 descendants of its own
- K170598: ZeroWire Mobile (2017), 0 descendants of its own

## Indications for use
The Foreseeson Custom Display's WIS1000 transmitter and receiver wirelessly transmit (60GHz) high quality audio and video (up to 1080p/60Hz) to displays during endoscopic and surgical procedures including arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), thorascopy, endoscopy (general, gastroenterological and ENT surgery) and general surgery. The WIS1000 wireless components are non-sterile reusable devices not intended for use in the sterile field.

Source page: https://510kreport.com/device/K112621
Methodology: https://510kreport.com/methodology