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510(k) Data Aggregation
K Number
K172120Device Name
Veress Needle
Manufacturer
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd.
Date Cleared
2017-09-14
(63 days)
Product Code
FHO, HIF
Regulation Number
876.1500Why did this record match?
Product Code :
FHO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
Device Description
The Veress Needle is a sterile and single-use product. It incorporated a spring loaded blunt stylet mechanism similar to the needle. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Veress Needle, available in 120 mm and 150 mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.
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K Number
K121370Device Name
VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE
Manufacturer
VECTEC
Date Cleared
2013-08-02
(452 days)
Product Code
FHO, FHP, HIF
Regulation Number
876.1500Why did this record match?
Product Code :
FHO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VECTEC Disposable Pneumoperitoneum Needle is a single-use, sterile device intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish a pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
Device Description
The VECTEC Disposable Pneumoperitoneum Needle is a disposable, single-use, sterile surgical tool used in laparoscopy for insufflation of the abdominal cavity prior to use of a trocar during abdominal surgery. The device is sterilized using a traditional, validated ethylene oxide procedure per ISO 11135-1: 2007 to a SAL of 10t and with acceptable residual EO levels per ISO 10993-7: 2008.
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K Number
K010779Device Name
MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
Manufacturer
GIBBONS SURGICAL CORP.
Date Cleared
2001-04-10
(26 days)
Product Code
FHO
Regulation Number
876.1500Why did this record match?
Product Code :
FHO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K970788Device Name
PNEUMO-MATIC INSUFFLATION NEEDLE
Manufacturer
APPLE MEDICAL CORP.
Date Cleared
1997-03-27
(23 days)
Product Code
FHO
Regulation Number
876.1500Why did this record match?
Product Code :
FHO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pneumo-Matic Insufflation Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
Device Description
The Pneumo-Matic Insufflation Needle is a sterile, disposable Veress needle which is available in a 14 gauge, 120mm or 150mm length. The devices are packaged 10 per box. The needle is equipped with a spring-loaded, round-tipped obturator. In addition, there is a "window" and visual indicator in the proximal handle which will visibly confirm penetration of the inner abdominal wall. Integral to the proximal handle is a "slide switch" which permits easy ON-OFF control of the gas flow. The most proximal end contains a male luer lock connector for secure gas line connection.
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K Number
K960574Device Name
ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM
Manufacturer
SHERWOOD MEDICAL CO.
Date Cleared
1996-08-05
(175 days)
Product Code
FHO
Regulation Number
876.1500Why did this record match?
Product Code :
FHO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter is intended to prevent pressure from developing in the chest, averting lung collapse and providing a means for fluid to drain from the chest cavity.
Device Description
The Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray will include all components commonly required to perform a chest drainage procedure in a single procedure-ready package. This procedure tray will be available in several configurations of tray components. The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter will be available in 8, 10 and 12 fr sizes. The device incorporates a blunt, multi-sideholed, springloaded inner cannula coaxially housed within a conventional sharp-beveled hollow needle. This entire assembly is housed within polyurethane tapered catheter, which is used as a standard small bore percutaneously placed thoracic catheter. The tapered catheter incorporates four distal side-holes to facilitate drainage.
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