# K994348: Ksea SCB-Rui

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Mar 3, 2000 after 71 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K232406: Karl Storz OR1™ SCB Control (WU300) (2023), 0 descendants of its own

## Indications for use
This instrument is intended for use by qualified surgeons and is used for central operation, central display, automatic initial setting, and interlocking operation of KSEA endoscopic devices.

Source page: https://510kreport.com/device/K994348
Methodology: https://510kreport.com/methodology