Cryo-Hit Models EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, and EP2T1

• • Terminated Z-1698-2008 FDA Unclassified (pre-2012) ·initiated 11 Dec 2007

  The warming catheter was manufactured with the inlet and outlet tubes switched.

510(k) Number

K012497 ↗

FDA Product Code

GEH

Models / Variants

EP6T5

FP5T5

FP5T3

EP2T2

EP1T1

EP2T1

FDA applicant

Galil Medical , Ltd.

Device Class

Class II

Regulation

21 CFR Part 878.4350

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Galil Medical Ltd →

• What are the Cryo-Hit models designed for?

  The Cryo-Hit models (EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, and EP2T1) are reusable cryosurgical accessories intended for controlled freezing of tissue during surgical procedures. They are specifically engineered for general and plastic surgery applications, enabling precise tissue ablation or preservation through localized freezing. Each model varies in probe size and configuration to meet distinct clinical needs, such as cosmetic or therapeutic interventions.

• How are the Cryo-Hit probes supplied and what does this imply for their use?

  The Cryo-Hit probes are supplied as reusable devices, meaning they are designed for multiple uses in sterile surgical environments. This implies that they must undergo proper cleaning, sterilization, and maintenance between procedures to ensure sterility and functionality. Adherence to standard surgical instrument protocols is essential to prevent contamination and maintain performance.

• Are the Cryo-Hit probes single-use or reusable, and why does this matter?

  The Cryo-Hit probes are reusable, not single-use. This distinction matters because reusable devices require rigorous sterilization and maintenance procedures between uses to ensure safety and efficacy. Proper handling and storage are critical to prevent cross-contamination and to preserve the device’s functionality for repeated clinical applications.

• What variations exist between the different Cryo-Hit models, and how do they differ?

  The Cryo-Hit models differ primarily in probe size and configuration. For example, the EP6T5 and FP5T5 models may have larger or differently shaped probes compared to the EP1T1 or EP2T1 models. These variations allow clinicians to select the appropriate probe for specific surgical needs, such as targeting different tissue depths or areas. The design differences accommodate tailored applications in general and plastic surgery.

• How should Cryo-Hit probes be stored to maintain their sterility and functionality?

  Cryo-Hit probes should be stored in accordance with standard surgical instrument protocols to maintain sterility and functionality. This includes keeping them in a clean, dry environment, protected from physical damage, and following manufacturer guidelines for packaging and storage. Proper storage ensures the probes remain ready for use when needed while minimizing the risk of contamination or degradation.