# K232406: Karl Storz OR1™ SCB Control (WU300)

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: Oct 3, 2023 after 54 days
- Product code: ODA (Endoscopic Central Control Unit)
- 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 K994348 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994348: Ksea SCB-Rui, KARL STORZ Endoscopy-America, Inc. (2000) Summary page 5.

## Indications for use
The KARL STORZ OR TM SCB CONTROL provides central control of compatible medical equipment in the operating room during diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K232406
Methodology: https://510kreport.com/methodology
