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Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 cm Length, 3 Aperture Reusable Cannula

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121218

by Andrew Technologies, LLC

Identifiers

510(k) Number
K121218 FDA 510(k)
FDA Product Code
QPB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.5040 FDA 510(k)
Regulation Number
878.5040 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a System, Suction, Lipoplasty for Removal (FDA classification II), designed for lipoplasty procedures. It features a reusable cannula with a 4mm diameter and a length of 26 cm, incorporating three apertures for enhanced tissue removal during suction-assisted lipoplasty. The cannula is intended to be used in conjunction with a console system for controlled fat aspiration in plastic surgery applications.

The Hydrasolve Console Sterile Treatment Kit includes a reusable cannula supplied in a sterile package, intended for single-use per patient procedure. It is regulated under 21 CFR 878.5040 and cleared via FDA 510(k) (K121218) as substantially equivalent to predicate devices. The cannula is designed for reusable use with appropriate cleaning and sterilization between procedures, adhering to medical device reprocessing standards. No MRI safety information is specified.

Frequently asked questions

Is the cannula in this kit designed for single-use or can it be reused between patients?

The cannula in the Hydrasolve Console Sterile Treatment Kit is intended for single-use per patient procedure, despite being described as reusable in its name. The kit is supplied sterile, and the cannula must be discarded after one use. However, the cannula itself is designed for reusable use between procedures if properly cleaned and sterilized according to medical device reprocessing standards, though this is not applicable to the sterile kit packaging provided.

What are the dimensions of the cannula included in this kit, and how does the aperture design affect its use?

The cannula in this kit has a 4mm diameter and a 26 cm length, with three apertures along its shaft. The three apertures are intended to enhance tissue removal during suction-assisted lipoplasty by increasing the surface area for fat aspiration, improving efficiency and reducing procedural time.

How is the kit packaged, and what should be considered for storage to maintain sterility?

The Hydrasolve Console Sterile Treatment Kit is supplied in a sterile package, ensuring it is ready for immediate use in a surgical setting. To maintain sterility, the kit should be stored in a clean, dry environment, protected from moisture, dust, and extreme temperatures. Follow manufacturer guidelines for shelf-life and expiration dates to ensure optimal performance and compliance with sterile processing protocols.

What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians?

This device was cleared via the FDA 510(k) pathway (K121218) under 21 CFR 878.5040, with a substantially equivalent determination to predicate devices. This means the device was evaluated by the FDA as meeting the same performance criteria as existing, legally marketed devices in its class (a Class II medical device). Clinicians can rely on this clearance as an indication that the device has undergone rigorous review for safety and effectiveness in suction-assisted lipoplasty procedures within plastic surgery applications.

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: Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4mm Dia, 26 ..., Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4mm Dia, 26 ..., PDF HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Andrew Technologies, LLC

Sources (1)

  • FDA 510(k) K121218 24 fields · synced Sep 19, 2026