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510(k) Data Aggregation
K Number
K162608Device Name
ClariFix Device
Manufacturer
Date Cleared
2017-02-14
(148 days)
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
ARRINEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ClariFix Device is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
Device Description
The ClariFix Device is a handheld, single patient-use, disposable cryosurgical device used for the destruction of tissue during surgical procedures. The device consists of a Handle attached to a Cannula with a Cryoprobe at the distal end. The ClariFix Device is provided sterile to the user. The user can select from two nitrous oxide Canister (cryogen Canister) sizes.
To perform cryosurgery, the ClariFix Device is removed from the sterile packaging and the desired cryogen Canister is inserted into the Handle. A Canister Cap is then tightened onto the Handle, which pierces the Canister. The cryogen is held in the Handle until the user opens a mechanical valve that allows cryogen to flow down the Cannula into the Cryoprobe.
The Cryoprobe is placed into contact with the target tissue via direct visualization. The Cannula can be rotated to ensure proper positioning. Once the Cryoprobe is in the desired position, cryosurgery can start.
The Cryoprobe is held in contact with the target location during cryosurgery. As cryogen flows into the Cryoprobe, the liquid partially evaporates and the inside of the Cryoprobe cools to < -80°C and a freezing zone forms in the adjacent tissue, destroying the unwanted tissue. Nitrous oxide is fully contained within the Cryoprobe and does not contact the tissue. Cryosurgery is stopped by the user closing the Valve. Once the Cryoprobe has thawed, it can be safely removed. Additional cycles can be initiated per the physician's discretion.
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K Number
K160669Device Name
ClariFix Device
Manufacturer
Date Cleared
2016-06-24
(107 days)
Product Code
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
ARRINEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ClariFix Device is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures.
Device Description
The ClariFix Device is a handheld, single patient-use, disposable cryosurgical device used for the destruction of tissue during surgical procedures. The device consists of a Handle attached to a Cannula with a Cryoprobe at the distal end. The ClariFix Device is provided sterile to the user. The user can select the desired nitrous oxide Canister (a.k.a. cryogen Canister) size from two different options.
To perform a treatment, the ClariFix Device is removed from the sterile packaging and the desired cryogen Canister is inserted into the Handle. A Canister Cap is then tightened onto the Handle which pierces the Canister. The cryogen is held in the Handle until the user opens a mechanical valve which allows cryogen to flow down the Cannula into the Cryoprobe.
Prior to initiating a treatment, the Cryoprobe is placed into contact with the target tissue via direct visualization. The Cannula can be rotated to ensure proper positioning. Once the Cryoprobe is in the desired position, treatment can start.
The Cryoprobe is held in contact with the treatment area during the treatment. As cryogen flows into the Cryoprobe, the liquid partially evaporates and the inside of the Cryoprobe cools to < - 80°C and a freezing zone forms in the adjacent tissue, destroying the unwanted tissue. Nitrous oxide is fully contained within the Cryoprobe and does not contact the tissue. Treatment is stopped by the user closing the Valve. Once the Cryoprobe has thawed it can be safely removed from the treatment area. Additional treatment cycles can be initiated per the physician's discretion.
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