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The Galil Medical 1.5 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The 1.5 CX Cryoablation Needles, when used with a Galil Medical Cryoablation System, are designed to destroy tissue by the application of extremely cold temperatures. A full list of specific indications can be found in the respective Galil Medical Cryoablation System User Manual. For reference, the indications for use from Galil Medical Cryoablation Systems User Manuals are provided below. The Galil Medical Cryoablation Systems are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, and urology, The systems are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions) by the application of extremely cold temperatures. The Galil Medical Cryoablation Systems have the following specific indications: • Urology Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH) • Oncology Ablation of cancerous or malignant tissue and benign tumors, and palliative intervention • Dermatology Ablation or freezing of skin cancers and other cutaneous disorders; Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the evelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of tumors of the skin - Gynecology Ablation of malignant neoplasia or benign dysplasia of the female genitalia - General surgery Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma - ENT Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth - Thoracic surgery (with the exception of cardiac tissue) - Proctology Ablation of benign or malignant growths of the anus or rectum

Galil Medical's IceSphere 1.5 CX Cryoablation Needle is a sterile, single use, disposable component, used in conjunction with a Galil Medical Cryoablation System to perform cryoablative destruction of tissue. The needle is intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. Galil Medical's IceSphere 1.5 CX Cryoablation Needle is a disposable 1.5 mm needle that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. The IceSphere 1.5 CX Cryoablation Needle offers a handle configured in a 90° angled configuration (to aid positioning of the needle within the CT imaging system gantry).

Galil Medical's IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, and urology. The systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. The Galil Medical IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles have the following specific indications: - · Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH") - · Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention) - · Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.) - · Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia) - · General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma) - · ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth) - · Thoracic surgery (with the exception of cardiac tissue) - · Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

Galil Medical's IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles are sterile, single use, disposable components, when used in conjunction with Galil Medical's Visual-ICE Cryoablation System to perform cryoablative destruction of tissue. The needles are intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. The IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles are disposable 2.1 mm needles that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. The IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles offer handles configured in a 90° angled configuration. The IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles were designed to provide the same cryoablation functionality with the same iceball shapes as compared to Galil Medical's predicate needles, IcePearl 2.1 CX and IceFORCE 2.1 CX (K152133). The new devices differ from the predicate devices in that the needle shaft is 55 mm longer than the needle shaft of the predicate devices. The longer shaft length was incorporated into the needles to treat deep-seated tumors in patients with a larger body habitus, while still allowing for CT gantry clearance using a 2.1 CX type needle.

Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The IcePearl 2.1 CX and lceFORCE 2.1 CX Cryoablation Needles are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. The Galil Medical IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles have the following specific indications: - . Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH") - . Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention) - . Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cvsts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.) - . Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia) - . General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma) - . ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth) - Thoracic surgery (with the exception of cardiac tissue) - . Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are sterile, single use, disposable components, when used in conjunction with Galil Medical's Visual-ICE Cryoablation System Software Revision 1.4.0, to perform cryoablative destruction of tissue. The needles are intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are disposable 2.1 mm needles that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. Both IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles offer handles configured as straight and in a 90° angled configuration (to aid positioning of the needle within the CT imaging system gantry). The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles were designed to provide the same cryoablation functionality with similar iceball shapes on a 2.1 mm shaft as compared to Galil Medical's predicate needles, IceRod CX (1.5 mm) needle and IceEDGE 2.4 mm needle. The IcePearl 2.1 CX and IceFORCE 2.1 CX Crvoablation Needles differ from the predicate devices in that the reconfigured heat exchanger has been relocated from the needle shaft to the needle handle and an additional vacuum insulated tube has been incorporated into the handle. The changes were made to ensure optimal freezing performance utilizing a 2.1 mm shaft. This Special 510(k) also contains changes to the Visual-ICE System software denoted as Software Release 1.4.0. Software Release 1.4.0 is an updated version of the Visual-ICE software previously cleared. There are no changes to the system hardware required as a result of the changes being made in the software. The following modifications were incorporated based on the added software support of the proposed IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles as well as customer and sales feedback to enhance the robustness of the software programming.

Galil Medical Cryoablation Systems are intended for cryoablative destruction of tissue during surgical procedures. The cryoablation systems is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. Galil Medical Cryoablation Systems have the following specific indications: • Urology Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH) • Oncology Ablation of cancerous or malignant tissue and benign tumors, and palliative intervention • Dermatology Ablation or freezing of skin cancers and other cutaneous disorders Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of tumors of the skin • Gynecology Ablation of malignant neoplasia or benign dysplasia of the female genitalia • General surgery Palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, recurrent cancerous lesions, ablation of breast fibroadenomas • ENT Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth • Thoracic surgery Ablation of arrhythmic cardiac tissue cancerous lesions • Proctology Ablation of benign or malignant growths of the anus or rectum, and hemorrhoids

Galil Medical's predicate IceSphere needles and Galil's proposed IceSphere needles are sterile, single use, disposable devices used in conjunction with Gali! Medical's cleared cryoablation systems (SeedNet, SeedNet Gold; Presice; Visual-ICE) for cryoablative destruction of tissue during surgical procedures. The needles have a sharp cutting tip, a 1.5mm (17G) shaft, a color-coded handle, gas tubing, and a connector. Galil's predicate and proposed iceSphere needles are available in 2 handle configurations: straight and 90°. The needles contain shaft markings to aid the physician in needle placement. Galil is requesting clearance of the proposed vacuum insulated IceSphere needles. The vacuum insulated modification represents a one-for-one component exchange within the internal non-patient contacting lumen of the cryoablation needle shaft.

The Galil Medical IceRod CX Cryoablation Needle is intended for cryoablative destruction of tissue during surgical procedures. The IceRod CX Cryoablation Needle is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. The Galil Medical IceRod CX Cryoablation Needle has the following specific indications: - Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH") - . Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention) - . Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas. mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.) - . Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia) - . General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma) - . ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth) - . Thoracic surgery (with the exception of cardiac tissue) - . Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

Galil is requesting clearance of a laser marking process improvement technique used to create the "markings" on the needle shaft of the previously cleared IceRod CX Needle (K121251). Galil's IceRod CX Needle (K121251) is a sterile, single use, disposable component used in conjunction with Galil Medical's Visual-ICE Cryoablation System (K113860, K123865) when performing cryoablative destruction of tissue. The needle has a sharp cutting tip, a 1.5mm (17G) shaft, a color-coded handle, gas tubing, and a connector. The handle is in a 90° configuration to aid positioning of the needle within the CT imaging system gantry. The IceRod CX needle contains shaft markings to aid the physician in needle placement. There are no changes to the marking dimensions on the needle. Only the marking technique has been modified. Since Galil is requesting clearance for a revised shaft marking process improvement technique for the IceRod CX Cryoablation Needle design itself (with the exception of the shaft marking method) has not changed. There are no other design, specification, process, or material changes to the needle; additionally, the model number of the needle is unchanged.

The Galil Medical IceRod CX Cryoablation Needle is intended for cryoablative destruction of tissue during surgical procedures. The IceRod CX Cryoablation Needle is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. The Galil Medical IceRod CX Cryoablation Needle has the following specific indications: - Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate . Hyperplasia "BPH") - . Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention) - . Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.) - . Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia) - . General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma) - ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth) . - . Thoracic surgery (with the exception of cardiac tissue) - . Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

The IceRod CX Cryoablation Needle is a sterile, single use, disposable component used in conjunction with Galil Medical's Visual-ICE Cryoablation System when performing cryoablative destruction of tissue. It is intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. The IceRod CX disposable cryoablation needle has a 17G shaft, a sharp cutting tip, a color-coded handle, a gas tube, and a connector containing a small PCB board capable of relaying needle information such as needle type, lot number, and expiration date information to Galil's Visual-ICE Cryoablation System. Additionally, the needle exhibits markings to aid in positioning the needle in tissue. The IceRod CX needle differs from the predicate devices in that the distal shaft of the needle contains a non-stick coating and Galil's i-Thaw electrical thaw technology can be used for FastThaw and/or Track Ablation following a cryoablation procedure when used with Galil's Visual-ICE Cryoablation System.

Galil Medical Cryoablation Systems are intended for cryoablative destruction of tissue during surgical procedures. The cryoablation systems is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. Galil Medical Cryoablation Systems have the following specific indications: - Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH") - . Oncology (ablation of cancerous or malignant tissue and benign turnors, and palliative intervention) - . Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell turnors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.) - Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia) . - . General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma) - . ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth) - . Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions) - . Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

The IceRod Plus 17G Cryoablation Needles are sterile, single use, disposable components used in conjunction with a Galil Medical Cryoablation System when performing cryoablative destruction of tissue. They are intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. The IceRod Plus needles are available in two configurations, straight and angled 90°. Each 17-gauge (17G) disposable cryoablation needle has a sharp cutting tip, a shaft, a color-coded handle, a gas tube, and a connector. Additionally, each needle exhibits markings every 5 mm to aid in positioning the needle in tissue. The IceRod Plus needles differ from the predicate device in that they contain an inner vacuum insulated tube to provide additional shaft insulation during a cryoablation procedure.

The Isis System is intended for cryogenic destruction of tissue during surgical procedures. The Isis System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. The Isis System has the following specific indications: - Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH") - Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention) - Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.) - Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia) - General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma) - ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth) - Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions) - Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

Cryosurgical unit with argon-cooled probes

The Presice system is intended for cryogenic destruction of tissue during surgical procedures. The Presice is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. The Presice system has the following specific indications: - Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH") - Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention) - Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses. cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.) - Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia) - General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas) - ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth) - Thoracic surgery (abla no cardiat tissue cancerous lesions) - Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids) The Presice System may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure.

Presice is a cryosurgical unit with argon-cooled probes. The principle changes between the Presice and the predicate SeedNet Family System include: Addition of new Electrical Thaw capability (i-Thaw™), enabling a choice between two thaw operating modes, Electrical or Helium Thaw. The new Electrical Thaw mode is supported by the use of new IceRod and SeedNet Cryo Needles, the IceSeed™ i-Thaw™ and the IceRod™ i-Thaw™ comprised of a new electrical thaw mechanism in addition to the Helium based thaw mechanism used in the cleared SeedNet Family Needles. Addition of a Multi-Thermal Sensor (MTS). Addition of touch screen user interface, thermal printer, USB port and frame grabber. Change of the software programming language from LabView to C++ and C#, while implementing the changes required to support the new electrical thaw feature and improving the user interface. In addition, the company has updated the operating system to Windows XP Pro, developers environment to .NET Framework and added certain off-the-shelf software (including drivers for the touch screen, thermal printer, USB port and frame grabber) for improved system functionality. Addition of a new name, the Presice™.

The SeedNet System is intended for cryogenic destruction of tissue during surgical procedures. The SeedNet System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. The SeedNet System has the following specific indications: - Urology (ablation of prostate tissue in cases of prostate cancer and t Benign Prostate Hyperplasia "BPH") - Oncology (ablation of cancerous or malignant tissue and benign I tumors, and palliative intervention) - Dermatology (ablation or freezing of skin cancers and other cutaneous . disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.) - Gynecology (ablation of malignant neoplasia or benign dysplasia of I the female genitalia) - General surgery (palliation of tumors of the rectum, hemorrhoids, ı anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma) - ENT (Palliation of tumors of the oral cavity and ablation of . leukoplakia of the mouth) - Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous . lesions) - Proctology (ablation of benign or malignant growths of the anus or # rectum, and hemorrhoids)

Cryosurgical unit with argon-cooled probes. The SeedNet Family System includes the SeedNet®/SeedNetGold® System, CryoThera® System, and Cryo-Hit® System. Modifications include the addition of a longer 17G (1.5mm) needle, a 90° needle, a needle/TS holder stand, and the addition of CT as an imaging modality to the device labeling, in addition to MRI and ultrasound.