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510(k) Data Aggregation
K Number
K993544Device Name
SPACE-OR RETRACTOR
Manufacturer
ADVANCED SURGICAL CONCEPTS (ASC)
Date Cleared
1999-12-22
(64 days)
Product Code
FFO
Regulation Number
876.4730Why did this record match?
Product Code :
FFO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Space-OR Retractor is a flexible internal retractor intended for the retraction of organs and tissues during abdominal surgery.
Device Description
The Space-OR is a flexible retractor which can be formed by the user into the desired shape for retraction of organs or tissues during abdominal surgery. The Space-OR can be left in position for a complete abdominal procedure.
In the relaxed position, the Space-OR is malleable and can be placed along a wound edge or in the abdominal cavity. The device can be shaped around the desired organs forming an optimum retractor. The Space-OR includes a connector for wall vacuum. When vacuum is pulled, the device then solidifies, staying in the position formed by the user. The Space-OR will maintain its shape, retracting the desired organs or areas until the clamp is released.
The vacuum applied to the Space-OR must be greater than 150 mmHg for the device to become solid. Once applied, the evacuation tubing is clamped and the vacuum pump removed. The device may be maintained in place for the duration of the surgery. If desired, the user can release the clamp on the vacuum, reposition the Space-OR and re-apply the vacuum.
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