# K974391: Karl Storz Endovision XL Endoscopic Camera System

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Imaging, Inc.
- Decided: Jan 30, 1998 after 70 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 K883943 (1988). 2 ancestors in all.
4 later devices descend from it; 3 cite 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)
- K950862: Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color Television Camera for Endoscopic Procedures, Karl Storz Imaging, Inc. (1995) Summary page 2.
- K883943: CCM-1 Video Camera System, Medical Concepts, Inc. (1988) Summary page 2.

## Most influential descendants
- K020336: Endoscopic Camera MC404/C3 (2002), 1 descendant of its own
- K080809: Iec Medsight and Medbright (2008), 0 descendants of its own
- K032544: VP-1000; Med Cam 100; VP-3000A; Med Cam 300 (2003), 0 descendants of its own
- K991416: Endoscopic Camera (1999), 0 descendants of its own

## Indications for use
The Karl Storz Imaging (KSI) Endovision XL Camera System is a color, television camera system designed for attachment to endoscopic visioning systems. The camera head is suitable for atachment to any rigid or flexible endoscope, including, such as sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes, nreteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope with a V-mount adapter. The camera is connected to the video processor via cable. The endoscopic image can be displayed on any standard operating room video monitor.

Source page: https://510kreport.com/device/K974391
Methodology: https://510kreport.com/methodology