# K990188: Intuitive Surgical Stereo View Endoscopic System, Model SVS-1

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Apr 1, 1999 after 71 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943307 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943307: 3D Surgical Endoscopy System for General Surgery, Olympus America, Inc. (1995). Our OCR of the scanned summary read K943305, FDA’s number for Olympus 3D Surgical Endoscopy System (Olympus America, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Olympus 3D Surgical Endoscopy System”.
- K960637: 5MM Endoscope, Origin Medsystems, Inc. (1996) Summary page 1.

## Most influential descendants
- K013952: Intuitive Surgical Stero View Endoscopic System (2002), 0 descendants of its own

## Recalls of this device
- Jul 11, 2005 · Not classified · Z-1423-05: Customer complaints state the needle had separated from the hub, resulting in blood exposure and/or dislocation of the needle.

## Indications for use
The Intuitive Surgical™ Stereo View Endoscopic System is intended for endoscopic viewing of internal surgical sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed to be used with the Intuitive Surgical™ Endoscopic Instrument Control System during thoracoscopic and laparoscopic surgical procedures

Source page: https://510kreport.com/device/K990188
Methodology: https://510kreport.com/methodology