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Found 3 results
510(k) Data Aggregation
K Number
K992250Device Name
CORE AUDIBLE TROCAR II
Manufacturer
CORE DYNAMICS, INC.
Date Cleared
1999-09-24
(80 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
CORE DYNAMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CORE Audible Trocar II has applications in gynecological laparoscopy, laparoscopic cholecystectomy and thoracic procedures.
Device Description
Not Found
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K Number
K992190Device Name
CORE POUCH
Manufacturer
CORE DYNAMICS, INC.
Date Cleared
1999-09-01
(64 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
CORE DYNAMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CORE Pouch is used when the surgeon desires to collect and remove tissue during laparoscopic procedures.
Device Description
Not Found
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K Number
K955490Device Name
LAPAROSCOPIC KNITTER
Manufacturer
CORE DYNAMICS, INC.
Date Cleared
1996-01-22
(80 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
CORE DYNAMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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