Search Results
Found 3 results
510(k) Data Aggregation
K Number
K020307Device Name
LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #LD112
Manufacturer
Date Cleared
2002-04-26
(87 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
HAKKO SHOJI CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The LAP DISC Hand Access Device is intended to provide extracorporeal extension of pneumoperitoneum and abdominal access for the surgeon during laparoscopic surgery. The LAP DISC is indicated for use in laparoscopic procedures, where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens. The LAP DISC has application in colorectal, urological and general surgical procedures. This indication for use includes the specific procedures which fall under these broad categories.
Device Description
The LAP DISC is a sterile, single-use disposable device. The LAP DISC is an abdominal wall closure unit consisting of three overlaid plastic rings that are interconnected by means of a silicone rubber. The two lower rings hold the abdominal wall to maintain peritoneal gas pressure. The bottom ring is a flexible ring made with a shape-memory alloy. The top ring has a structure similar to the aperture in a camera (an Iris Valve). Because the aperture of the Iris Valve can be adjusted continuously, the system can maintain constant peritoneal gas pressure while allowing the insertion of the surgeon's hand and alternatively, it can be used as an insertion site.
Ask a Question
Ask a specific question about this device
K Number
K961151Device Name
SPINAL NEEDLES
Manufacturer
Date Cleared
1997-03-19
(362 days)
Product Code
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
HAKKO SHOJI CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K961152Device Name
TUOHY EPIDURAL NEEDLES
Manufacturer
Date Cleared
1997-03-19
(362 days)
Product Code
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
HAKKO SHOJI CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
Page 1 of 1