CVAC Aspiration System + CVAC Image Processor
FDA 510(k)Class II (US FDA 510(k))
by Calyxo, Inc.
Identifiers
- 510(k) Number
- K233472 FDA 510(k)
- FDA Product Code
- FED FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CVAC Aspiration System with CVAC Image Processor is a sterile single-use endoscopic overtube designed for urological procedures. It combines a steerable ureteral catheter with a reusable, software-controlled image processor to facilitate the removal of urinary stones during laser lithotripsy, ensuring continuous clearance of stone fragments.
This system is intended for use in endoscopic urological procedures and is supplied as a sterile single-use catheter paired with a reusable image processor. It has received FDA 510(k) clearance under the Gastroenterology-Urology advisory committee and is classified as a Class II device. The device is not MRI-compatible and requires proper storage and handling as specified in the manufacturer’s instructions.
Frequently asked questions
What is the primary purpose of the CVAC Aspiration System with CVAC Image Processor in urological procedures?
The CVAC Aspiration System is designed to assist in the removal of urinary stones during laser lithotripsy by combining a steerable ureteral catheter with a reusable image processor. This setup ensures continuous clearance of stone fragments, improving efficiency and precision during endoscopic urological procedures.
Is the CVAC Aspiration System single-use or reusable, and how does this affect its use?
The CVAC Aspiration System is supplied as a sterile single-use catheter, meaning each catheter is intended for one procedure only. The reusable component is the software-controlled image processor, which pairs with the disposable catheter. This design ensures patient safety by preventing cross-contamination while maintaining functionality for multiple uses of the processor.
Can the CVAC Aspiration System be used with MRI equipment, and what storage precautions should be taken?
The CVAC Aspiration System is not MRI-compatible, so it should never be used or stored near MRI machines. The manufacturer’s instructions specify proper storage and handling to maintain sterility and functionality, including keeping the system in its original packaging until ready for use.
How was the regulatory approval for this device determined, and what does that mean for its use?
The CVAC Aspiration System received FDA 510(k) clearance under the Gastroenterology-Urology advisory committee, with a decision labeled as *Substantially Equivalent* (SESE). This means the FDA determined it is as safe and effective as a legally marketed predicate device, allowing it to be marketed for its intended use in endoscopic urological procedures without additional clinical trials.
What types of procedures is the CVAC Aspiration System intended to support, and how does the image processor enhance its functionality?
The system is specifically designed for endoscopic urological procedures, particularly those involving laser lithotripsy where stone fragments need to be cleared. The software-controlled image processor provides real-time visualization and guidance, allowing clinicians to steer the catheter more precisely and continuously aspirate fragments, improving procedural outcomes.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Calyxo CVAC System | All-in-One Kidney Stone Treatment, PDF Aspiration System, Calyxo Updates Use Instructions for CVAC Aspiration Systems, CVAC Aspiration System + CVAC Image Processor (K233472) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233472 | Class II | Active |
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Manufacturer
- Manufacturer
- Calyxo, Inc.
Sources (1)
- FDA 510(k) K233472 24 fields · synced Sep 19, 2026