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CryoSpray Ablation System, Model CC2-NAM

FDA 510(k)

Class II (US FDA 510(k))

510(k) K072651

by CSA Medical, Inc.

Identifiers

510(k) Number
K072651 FDA 510(k)
FDA Product Code
GEH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4350 FDA 510(k)
Regulation Number
878.4350 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CryoSpray Ablation System, Model CC2-NAM, is a cryosurgical device designed for the destruction of unwanted tissue. Classified as a cryosurgical unit with accessories, it employs controlled freezing to achieve tissue ablation, primarily within general and plastic surgery applications. This system is intended for use in procedures requiring precise cryogenic treatment, leveraging liquid nitrogen-based cryotherapy to target and remove tissue safely and effectively.

The CryoSpray Ablation System, Model CC2-NAM, operates as a reusable, non-sterile cryosurgical unit intended for use in controlled clinical environments. It is powered by a 120VAC, 50/60 Hz, 550W electrical supply and is regulated under FDA 510(k) clearance (K072651) as an abbreviated submission. The system is supplied with associated cryosurgical accessories, and its use requires adherence to sterile techniques when applied clinically. No MRI safety information or single-use specifications are provided in the regulatory data.

Frequently asked questions

What types of clinical procedures is the CryoSpray Ablation System primarily used for?

The CryoSpray Ablation System, Model CC2-NAM, is designed for cryosurgical procedures where controlled freezing is required to destroy unwanted tissue. It is specifically intended for use in general and plastic surgery applications, such as tissue ablation where precision cryotherapy is needed. The system leverages liquid nitrogen-based cryotherapy to safely target and remove tissue in controlled clinical settings.

Is the CryoSpray Ablation System reusable or single-use, and what are the sterility requirements?

The CryoSpray Ablation System itself is reusable and non-sterile, meaning it is not pre-sterilized for direct patient use. However, when applied clinically, sterile techniques must be adhered to during use, as the system is paired with cryosurgical accessories that are intended for sterile application. This ensures safe and hygienic patient treatment.

What electrical specifications must be met for operation, and is there any special handling required?

The CryoSpray Ablation System requires a 120VAC power supply operating at 50/60 Hz with a 550W draw. No special handling instructions beyond standard electrical safety protocols are explicitly mentioned in the regulatory data, but since it is a reusable medical device, it should be maintained and inspected according to manufacturer guidelines to ensure proper function and safety.

Are there different models or sizes available for this system, and if so, how are they distinguished?

The provided data only specifies one model, the CC2-NAM, of the CryoSpray Ablation System. While the system includes multiple cryosurgical accessories (listed via FEI numbers), these are not differentiated by size or model in the regulatory documentation. Accessories are likely interchangeable or tailored for specific procedural needs, but no distinct sizing or model variations are explicitly described for the core system itself.

How was the regulatory pathway for this device determined, and what does that mean for its use?

The CryoSpray Ablation System was cleared via an FDA 510(k) submission (K072651), classified as substantially equivalent to a predicate device. This means the FDA determined it met the same safety and effectiveness requirements as an existing, legally marketed cryosurgical unit. Clinically, this clearance indicates the device is intended for cryosurgical ablation in general and plastic surgery and is regulated under 21 CFR 878.4350, ensuring compliance with U.S. medical device standards.

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: CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM (K072651) — FDA 510 (k ..., Cc 2 Media | CSA Medical Inc | Bioz, Cryospray Ablation System, Model Cc2-nam 510 (k) FDA Premarket ..., CSA Medical Inc Model CC2 NAM General Purpose Cryosurgical Unit 120VAC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
CSA Medical, Inc.

Sources (1)

  • FDA 510(k) K072651 24 fields · synced Sep 19, 2026