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Found 4 results
510(k) Data Aggregation
K Number
K072814Device Name
CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
Manufacturer
COVIDIEN
Date Cleared
2008-04-16
(198 days)
Product Code
KDD, GEI
Regulation Number
878.4800Why did this record match?
Product Code :
KDD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures.
Device Description
Convenience kit of laparoscopic instruments. The convenience kit contains various configurations of tools for the performance of laparoscopic procedures. These tools provide laparoscopic access, tissue dissection and manipulation, hemostasis, and specimen collection.
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K Number
K011514Device Name
INSTRUMENTS FOR ONE TIME USE - DISPOSABLE
Manufacturer
KENCAP LTD.
Date Cleared
2001-08-13
(88 days)
Product Code
KDD
Regulation Number
878.4800Why did this record match?
Product Code :
KDD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K971317Device Name
NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS
Manufacturer
NATIONAL HEALTHCARE MFG. CORP.
Date Cleared
1997-05-08
(29 days)
Product Code
KDD
Regulation Number
878.4800Why did this record match?
Product Code :
KDD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
Orthopedic Kit or Tray
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K Number
K960456Device Name
DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY
Manufacturer
DENVER BIOMATERIALS, INC.
Date Cleared
1996-04-01
(62 days)
Product Code
KDD
Regulation Number
878.4800Why did this record match?
Product Code :
KDD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Denver® Paracentesis Needle, Paracentesis Needle with Drainage Binc, and the Denver Traracentesis Tray are indicated for use in removing from cac personed to be used for both diagnostic and therapeutic abdominal paracentesis procedures.
Device Description
The Denver® Paracentesis Needle is a sterile device, for single use only. It is not to be resterilized. Components in the fluid path are non pyrogenic. This device consists of an inner two-part trocar, an outer drainage cannula, and a trocar/cannula housing. The inner two-part trocar is a rounded, closed end tube with side holes, coaxially housed within a sharp-beveled hollow needle and the outer drainage cannula. The outer drainage cannula has a beveled tip and distal side holes to facilitate drainage.
As the two-part trocar penetrates the abdominal wall, the blunt portion of the trocar is forced back within the shaft of the needle portion of the trocar, exposing the sharp-beveled needle. The trocar/cannula housing contains a red indicator which is visible when the sharp-beveled needle is exposed. When the needle encounters low resistance, such as when the abdominal cavity is entered, the blunt portion of the trocar automatically re-extends out beyond the sharp needle, thereby helping protect against inadvertent organ puncture. Once the blunt portion of the trocar re-extends beyond the needle, the red indicator is no longer visible. Proper position in an area of fluid may also be confirmed by attaching a syringe to the end of the device and attempting aspiration.
Once in the abdominal cavity, the two-part trocar is removed, leaving the outer drainage cannula and housing in place for the paracentesis procedure.
The Denver® Paracentesis Needle with Drainage Line is a sterile device intended for single use only. It is not to be resterilized. The product contains one Denver® Paracentesis Needle, one drainage tubing line, and connectors to allow attachment to wall suction or a vacuum bottle.
The Denver® Paracentesis Tray is a sterile device intended for single use only. It is not to be resterilized. The tray contains one Denver® Paracentesis Needle, one drainage tubing line, connectors to allow attachment to wall suction or a vacuum bottle, and the primary components needed for performing the paracentesis procedure.
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