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Found 3 results
510(k) Data Aggregation
K Number
K041783Device Name
POLAR WAND
Manufacturer
CHEK-MED SYSTEMS
Date Cleared
2004-09-28
(89 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CHEK-MED SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Polar Wand Cryotherapy System is indicated for the endoscopic ablation of tissue in the gastrointestinal tract.
Device Description
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K Number
K021387Device Name
POLAR WAND
Manufacturer
CHEK-MED SYSTEMS
Date Cleared
2002-07-31
(90 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CHEK-MED SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Polar Wand Cryotherapy System is used for ablation of unwanted tissue in the fields of dermatology, gynecology, general surgery, urology, and gastroenterology. The system may be used with a variety of cryogens, e.g. carbon dioxide, nitrous oxide, argon, krypton.
Device Description
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K Number
K993951Device Name
SPOT ENDOSCOPIC MARKER
Manufacturer
CHEK-MED SYSTEMS
Date Cleared
2000-02-18
(88 days)
Product Code
NBG
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
CHEK-MED SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IS INDICATED FOR ENDOSCOPICALLY MARKING LESIONS IN THE GE TRACT MARKING LESTONS IN CONSTITUTIONATES WHEN THE REQUIRE SURGICAL REMOVAL WITHIN (30) THEFTY DAYS .
Device Description
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