Search Results
Found 1 results
510(k) Data Aggregation
K Number
K981598Device Name
HERNIA MESH STABILIZER
Manufacturer
MEDIVICES CO.
Date Cleared
1998-07-01
(58 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MEDIVICES CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Temporary mesh fixation to the inner surface of the abdominal wall to facilitate the permanent placement, by stapling, of the mesh when used in the standard fixation technique for Laparoscopic Hernia Repair.
Device Description
Stylet with 16 gauge Cannula, for insertion through a separate incision into the abdominal cavity, in Laparoscopic Hernia Repair, to capture and temporarily hold. with spring retraction, the surgical mesh against the abdominal wall for permanent attachment by stapling. On completion of stapling, the stylet and cannula are advanced to release the mesh, enclose the hook within the cannula and safely remove the Hernia Mesh Stabilizer from the surgical site.
Ask a Question
Page 1 of 1