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510(k) Data Aggregation
K Number
K241827Device Name
Microwave Ablation Generator (KY-2000A, KY-2100A)
Manufacturer
Canyon Medical Inc.
Date Cleared
2024-09-26
(94 days)
Product Code
NEY
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Canyon Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Microwave Ablation Generator is indicated for the coagulation (ablation) of soft tissue. The device is not intended for cardiac use.
Device Description
Microwave ablation is a kind of thermal ablation technology used in the treatment of soft tissue, utilizing electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) to produce tissue-heating effects. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis.
Microwave Ablation Generator consists of microwave source, pump, foot pedal etc. It is a software-controlled microwave generator that delivers the microwave energy at a working frequency of 2450 MHz and can meet various clinical needs of soft tissue ablation therapy. Microwave Ablation Generator delivers microwave energy to Microwave Ablation Antennas into the target tissue through Microwave Ablation Cable(sterile or non-sterile cable). When reaching the target temperature, the soft tissue will be damaged, leading to irreversible necrosis. The Microwave Ablation Temperature Probe is applied to monitor the temperature of the target location and to protect important organs and tissues in the periphery of the lesion from unexpected damage by microwave energy. Coagulated zones are monitored during treatment using appropriate imaging techniques.
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K Number
K241825Device Name
Microwave Ablation Antennas
Manufacturer
Canyon Medical Inc.
Date Cleared
2024-09-20
(88 days)
Product Code
NEY
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Canyon Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Microwave Ablation Antennas, in conjunction with the compatible Microwave Ablation Generator, is intended for coagulation (ablation) of soft tissue. This device is not intended for cardiac use.
Device Description
Microwave ablation is a kind of thermal ablation technology used in the treatment of soft tissue, utilizing electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) to produce tissue-heating effects. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis. Microwave Ablation Antennas generally consist of the Microwave Ablation Antennas, Microwave Ablation Cable. This device is single-use and sterilized by EO. During ablation, Microwave Ablation Antennas will be punctured into the target tissue of the patients. In order to achieve the intended use, Microwave Ablation Antennas shall be connected with Microwave Ablation Generator which deliver microwave energy to Microwave Ablation Antennas through Microwave Ablation Cable (sterile or non-sterile cable). When reaching the target temperature, the soft tissue will be damaged leading to irreversible necrosis. Coagulated zones are monitored during treatment using appropriate monitoring techniques.
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K Number
K233031Device Name
M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle
Manufacturer
Canyon Medical Inc.
Date Cleared
2024-01-17
(114 days)
Product Code
KNW
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
Canyon Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.
Semi-Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.
Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.
Device Description
Automatic Disposable Biopsy Needle, Semi-automatic Disposable Biopsy Needle and Coaxial Biopsy Needle are hand-operated, non-electronic, surgical instruments.
Automatic Disposable Biopsy Needle is designed for the automatic extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/ testing. Automatic Disposable Biopsy Needle is first loaded and then inserted into the edge of the target tissue. Then, the inner needle rod is threaded into the target lesion (automatic firing), then, the outer needle tube is fired to push forward, and the tissue sample is cut through the relative movement of the outer needle tube and the inner needle rod of the biopsy needle, later, the tissue sample is cut off and stored in the sampling groove. Finally, specimen was removed after withdrawing the biopsy needle.
Semi-automatic Disposable Biopsy Needle is designed for the extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/testing. The semi-automated biopsy needle requires manual advancement of the inner needle to expose the specimen notch. With pressure on its plunger, a spring action rapidly advances the outer needle (cutting cannula) over the specimen notch of the inner needle.
Coaxial Biopsy Needle is used with biopsy needles to guide the insertion of biopsy needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is supplied with trocar tip stylet with or without blunt tip needle.
All of these devices are sterile with a Sterility Assurance Level (SAL) of 10-6, nonpyrogenic and single-use devices. The ultrasound, X-ray, CT and other equipments are used to guide the puncture and sampling. These devices cannot be used under MRI.
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K Number
K222865Device Name
M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle
Manufacturer
Canyon Medical Inc.
Date Cleared
2023-04-03
(193 days)
Product Code
KNW
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
Canyon Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone.
Semi-Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone.
Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone.
Device Description
Automatic Disposable Biopsy Needle, Semi-automatic Disposable Biopsy Needle and Coaxial Biopsy Needle are hand-operated, non-electronic, surgical instruments.
Automatic Disposable Biopsy Needle is designed for the automatic extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/ testing. Automatic Disposable Biopsy Needle is first loaded and then inserted into the edge of the target tissue. Then, the inner needle rod is threaded into the target lesion (automatic firing), then, the outer needle tube is fired to push forward, and the tissue sample is cut through the relative movement of the outer needle tube and the inner needle rod of the biopsy needle, later, the tissue sample is cut off and stored in the sampling groove. Finally, specimen was removed after withdrawing the biopsy needle.
Semi-automatic Disposable Biopsy Needle is designed for the extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/testing. The semi-automated biopsy needle requires manual advancement of the inner needle to expose the specimen notch. With pressure on its plunger, a spring action rapidly advances the outer needle (cutting cannula) over the specimen notch of the inner needle.
Coaxial Biopsy Needle is used with biopsy needles to quide the insertion of biopsy needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is supplied with trocar tip stylet with or without blunt tip needle.
All of these devices are sterile with a Sterility Assurance Level (SAL) of 10-6, nonpyrogenic and single-use devices.
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