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510(k) Data Aggregation
K Number
K001915Device Name
GRAFT MARKER RINGManufacturer
Date Cleared
2001-04-27
(308 days)
Product Code
Regulation Number
870.3450Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
T. KOROS SURGICAL INSTRUMENTS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K002755Device Name
NON-ABSORBING STERNATOMY MONOFILAMENT SUTUREManufacturer
Date Cleared
2000-12-04
(90 days)
Product Code
Regulation Number
888.3030Type
TraditionalPanel
OrthopedicReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
T. KOROS SURGICAL INSTRUMENTS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K954016Device Name
VIDEOSCOPE W/IRRIGATION SHEATHManufacturer
Date Cleared
1996-01-25
(153 days)
Product Code
Regulation Number
888.1100Type
TraditionalPanel
OrthopedicReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
T. KOROS SURGICAL INSTRUMENTS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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