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510(k) Data Aggregation
K Number
K014216Device Name
SECCA SYSTEM
Manufacturer
CURON MEDICAL, INC.
Date Cleared
2002-03-21
(90 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
CURON MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Secca™ System is intended for general use in the electrosurgical coagulation of tissue and intended for use specifically in the treatment of fecal incontinence in those patients with incontinence to solid or liquid stool at least once per week and who have failed more conservative therapy.
Device Description
Radiofrequency electrosurgical generator and electrosurgical accessories
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K Number
K010210Device Name
CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400
Manufacturer
CURON MEDICAL, INC.
Date Cleared
2001-02-21
(29 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
CURON MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002898Device Name
CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST
Manufacturer
CURON MEDICAL, INC.
Date Cleared
2000-10-17
(29 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
CURON MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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