# K090814: Modification to Gyrus Acmi Invisio Icn, Models Icn-0564 and Icn-0565

- Pathway: 510(k) (Special)
- Applicant: Gyrus Acmi, Inc.
- Decided: Apr 20, 2009 after 26 days
- Product code: FAJ (Cystoscope And Accessories, Flexible/Rigid)
- 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: 6 generations back to K931154 (1993). 17 ancestors in all.
No later device cites it as a predicate yet.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042225: Acmi Invisio Icn, Models Icn-0564 and Icn-0565, Acmi Corporation (2004) Summary page 1.

## Indications for use
The Gyrus ACMI® Invisio® ICN (CystoNephroscope) System (which includes the ICN Endoscope and Controller) is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K090814
Methodology: https://510kreport.com/methodology