# K990635: Vista Stereoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Vista Medical Technologies, Inc.
- Decided: May 19, 1999 after 82 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: 3 generations back to K923160 (1992). 6 ancestors in all.
41 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931478: Zeiss Opmi L Stereo-Laparoscope, Carl Zeiss, Inc. (1994) Summary page 1.
- K950985: Zeiss Endolive Stero Endoscope, Carl Zeiss, Inc. (1995) Summary page 1.
- K970214: 3 Dimensional Video Endoscope, Oktas (1997) Summary page 1.

## Most influential descendants
- K082355: Visionsense Stereoscopic Vision System (2008), 37 descendants of its own
- K141002: VS3 Stereoscopic High Definition Vision System (2014), 36 descendants of its own
- K152204: VS3-IR system (2015), 34 descendants of its own
- K162882: KARL STORZ ICG Imaging System (2017), 32 descendants of its own
- K171238: KARL STORZ ICG Imaging System (2017), 31 descendants of its own

## Indications for use
The Vista StereoScope System is intended for use in endoscopic procedures and all types of video assisted procedures, including general endoscopic and laparoscopic, thoracic, anterior and posterior spinal and as an aid in visualization of cardiac structures.

Source page: https://510kreport.com/device/K990635
Methodology: https://510kreport.com/methodology