# K260013: CVAC Image Processor

- Pathway: 510(k) (Traditional)
- Applicant: Calyxo, Inc.
- Decided: Mar 6, 2026 after 60 days
- Product code: FGB (Ureteroscope 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: 10 generations back to K931154 (1993). 30 ancestors in all.
No later device cites it as a predicate yet.
2 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233472: CVAC Aspiration System + CVAC Image Processor, Calyxo, Inc. (2024) Summary page 5.

## Indications for use
The CVAC Image Processor is only to be used with the CVAC Aspiration System to provide treatment and removal of urinary stones (kidney stones, fragments, and dust) and endoscopic examination of the urinary tract and the interior of the kidney.

Source page: https://510kreport.com/device/K260013
Methodology: https://510kreport.com/methodology