# 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

- Pathway: 510(k) (Traditional)
- Applicant: Nds Surgical Imaging
- Decided: Apr 21, 2010 after 89 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: 1 generation back to K081995 (2008). 1 ancestor in all.
7 later devices descend from it; 3 cite 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)
- K081995: Stryker Vision Elect Whdtv (Stryker VE Whdtv), Stryker Endoscopy (2008) Summary page 1.

## Most influential descendants
- K112621: WIS1000 (2012), 4 descendants of its own
- 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 NDSsi ZeroWire Duo Wireless RD Video Transfer System is a paired transmitter and receiver, intended for delivery of video signals over a radio-frequency link to a video display during endoscopic and general surgical procedures. The ZeroWire wireless device is a non-sterile reusable device not intended for use in the sterile field. It is intended for use by qualified physicians having complete knowledge of these surgical procedures.

Source page: https://510kreport.com/device/K100195
Methodology: https://510kreport.com/methodology