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510(k) Data Aggregation
K Number
K060555Device Name
SPRAYGENIX CRYO ABLATION SYSTEM
Manufacturer
CRYMED TECHNOLOGIES, INC.
Date Cleared
2006-04-21
(50 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CRYMED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SprayGenix™ Cryo Ablation System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.
Device Description
The SprayGenix™ Cryo Ablation System is a cryosurgical device. consisting of an electronic console, cryo-catheter, nasal/oral gastric tube and cryogen delivery system. The SprayGenix™ Cryo Ablation System is used to destroy unwanted tissue by application of extreme cold to a selected site. Liquid Nitrogen is stored in a tank and then propelled through a cryo-catheter to perform the cryo-ablation procedure. The catheter is placed in the appropriate position through the use of visual observation. The cryo-catheter applies the cryogen to a selected area and freezes the unwanted tissue. Cryosurgical procedures are used when surgical resection is not indicated, and may also provide an alternative to typical resection in certain cases.
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K Number
K040809Device Name
CRYMED CRYO-ABLATOR
Manufacturer
CRYMED TECHNOLOGIES, INC.
Date Cleared
2004-05-21
(53 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CRYMED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CryMed Cryo-Ablator System is intended to be used as a cryosurgical tool for use in dermatology, gynecology and general surgery.
Device Description
The Cryo-Ablator System is a cryosurgical device, consisting of an electronic console, cryo-catheter and cryogen tank, The Cryo-Ablator System is used to destroy unwanted tissue by application of extreme cold to a selected site. Liquid Nitrogen is stored in a tank and then propelled through a crvo-catheter to perform the cryo-ablation procedure. The catheter is placed in the appropriate position through the use of visual observation. The cryo-catheter applies the cryogen to a selected area and freezes the unwanted tissue. Cryosurgical procedures are used when surgical resection is not indicated, and may also provide an alternative to typical resection in certain cases.
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