# K233472: CVAC Aspiration System + CVAC Image Processor

- Pathway: 510(k) (Traditional)
- Applicant: Calyxo, Inc.
- Decided: Feb 2, 2024 after 100 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931154 (1993). 29 ancestors in all.
3 later devices descend from it; 3 cite it directly.
2 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200072: Lumipulse G ß-Amyloid Ratio (1-42/1-40), Fujirebio Diagnostics,Inc. (2022). Our reading of the summary gave K200149, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN200072, Lumipulse G ß-Amyloid Ratio (1-42/1-40) (Fujirebio Diagnostics,Inc.), granted May 4, 2022; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K180367: Ureterorenoscope System, Shanghai AnQing Medical Instrument Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K261447: CVAC® Aspiration System (2026), 0 descendants of its own
- K260965: CVAC Aspiration System (2026), 0 descendants of its own
- K260013: CVAC Image Processor (2026), 0 descendants of its own

## Recalls of this device
- Feb 19, 2025 · Class I · Z-1396-2025: Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidn

## 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 (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/K233472
Methodology: https://510kreport.com/methodology