# K994090: Karl Storz Autoclavable Camera Head

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Imaging, Inc.
- Decided: Feb 4, 2000 after 63 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- 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). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883943: CCM-1 Video Camera System, Medical Concepts, Inc. (1988) Summary page 1.
- K950862: Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color Television Camera for Endoscopic Procedures, Karl Storz Imaging, Inc. (1995) Summary page 1.
- K942358: Autoclaveable Medicam 900 Digicon Camera, M.P. Video, Inc. (1994) Summary page 1.

## Most influential descendants
- K080809: Iec Medsight and Medbright (2008), 0 descendants of its own

## Indications for use
The Karl Storz Imaging (KSI) Autoclavable camera head is a color, television camera. suitable for use with any rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled t the endoscope. The camera head may be used with any current, compatible KSI camera control unit (CCU). The endoscopic image can then be displayed on any standard operating room video monitor.

Source page: https://510kreport.com/device/K994090
Methodology: https://510kreport.com/methodology