Kalera Vacuum Aspiration Catheter (K-VAC)
510(k) K200419
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200419 | Date22 May 2020 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FED
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Kalera Vacuum Aspiration Catheter (K-VAC) is a vacuum-assisted aspiration catheter designed for endoscopic urological procedures. It provides a conduit for irrigation and aspiration of urinary stones, facilitating their removal during interventions such as ureteroscopy or percutaneous nephrolithotomy. The device features a large aspiration lumen and a continuous wire mesh shaft, enhancing its efficiency in stone fragmentation and clearance. Its radiopaque markers improve visibility under fluoroscopy, ensuring precise placement and operation.
The K-VAC is supplied as a reusable medical device, intended for use in controlled clinical settings such as operating rooms or endoscopy suites. It is not sterile at time of shipment but is designed for single-use per procedure, adhering to standard infection control protocols. The device is classified under FDA Class II (876.1500) and holds a FDA 510(k) clearance (K200419), affirming its substantial equivalence to predicate devices. Storage and handling follow manufacturer guidelines to maintain functionality and safety.
Questions
AI-generated answers, 1 Oct 2026
What is the Kalera Vacuum Aspiration Catheter (K-VAC) used for?
The K-VAC is designed specifically for endoscopic urological procedures, such as ureteroscopy or percutaneous nephrolithotomy. It provides a conduit for irrigation and aspiration of urinary stones, improving their fragmentation and clearance during surgery. The large aspiration lumen and continuous wire mesh shaft optimize efficiency, while radiopaque markers ensure visibility under fluoroscopy for precise placement.
Is the K-VAC supplied sterile at the time of shipment?
No, the K-VAC is not sterile at the time of shipment. It is intended for single-use per procedure, adhering to standard infection control protocols. Sterilization must be performed by the facility prior to use, following manufacturer guidelines to maintain safety and functionality.
How is the K-VAC classified and regulated?
The K-VAC is classified under FDA Class II (product code 876.1500) and holds a 510(k) clearance (K200419). This classification and clearance affirm its substantial equivalence to predicate devices, ensuring it meets regulatory standards for safety and effectiveness in its intended use for urological procedures.
Can the K-VAC be reused?
No, the K-VAC is designed for single-use per procedure. While it is supplied as a reusable device in terms of its physical construction, it is intended to be discarded after one use to comply with infection control protocols and maintain patient safety. Reuse is not recommended or supported by the manufacturer.
What special features does the K-VAC have for improved visibility during procedures?
The K-VAC includes radiopaque markers, which enhance visibility under fluoroscopy. These markers allow clinicians to precisely locate and operate the catheter during procedures, reducing the risk of misplacement and improving the accuracy of stone removal.