# K261447: CVAC® Aspiration System

- Pathway: 510(k) (Traditional)
- Applicant: Calyxo, Inc.
- Decided: Sep 15, 2026 after 137 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 Aspiration System and CVAC Image Processor consists of a sterile single use, steerable ureteral catheter and a reusable software-controlled image processor. It is intended to establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones (e.g., kidney stones, fragments, and dust). It employs flexible ureteroscopy within the urinary tract for endoscopic examination of the urinary tract and the interior of the kidney. The steerable ureteral catheter is used for irrigation and aspiration of kidney stones and stone dust with dedicated irrigation and vacuum channels under ureteroscopy. The CVAC Aspiration System and CVAC Image Processor can be used with additional accessories to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K261447
Methodology: https://510kreport.com/methodology