# K021776: Ksea Quadro Switch

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy
- Decided: Aug 15, 2002 after 78 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The KSEA Quadro Switch, in conjunction with its associated handpiece, functions as a suction/irrigation control switch device to control the rinsing and removal of carbon deposits, blood clots, or excised tissue from operative sites during surgical procedures.

Source page: https://510kreport.com/device/K021776
Methodology: https://510kreport.com/methodology