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510(k) Data Aggregation
K Number
K172132Device Name
CleanCision Wound Retraction and Protection System
Manufacturer
Date Cleared
2017-10-25
(103 days)
Product Code
Regulation Number
878.4371Why did this record match?
Applicant Name (Manufacturer) :
Prescient Surgical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CleanCision™ Wound Retraction System is intended for use by a surgeon during abdominal surgery to: retract the surgical incision, provide access to the abdominal cavity, and irrigate the surgical wound edge. The device may aid in the prevention of wound edge contamination. This device is intended to deliver a sterile irrigant solution and serve as a conduit for fluid removal from the surgical wound edge.
Device Description
The CleanCision™ Wound Retraction and Protection System is a sterile, single-use irrigating wound retractor device that integrates surgical retraction, wound barrier protection, and fluid delivery and removal. The wound barrier protection component is comprised of a flexible, double-walled sheath with an impermeable inner layer that protects the wound edges from contamination. The wound retraction component is formed by attaching the sheath to a fixeddiameter ring at the bottom, designed to be inserted into the abdominal cavity, and a radiallyadjustable upper retraction ring at the top, designed to remain outside of the body and be actuated to achieve wound retraction. The double-walled sheath also includes integrated fluid delivery. Fluid is delivered via gravitational feed from an external fluid bag into the device and delivered to the wound edges through the permeable outer layer of the sheath. Excess fluid is removed through the bottom ring via a connection with the hospital's standard vacuum suction mechanism.
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K Number
DEN150038Device Name
CleanCisionTM Wound Retraction and Protection System
Manufacturer
Date Cleared
2016-12-16
(491 days)
Product Code
Regulation Number
878.4371Why did this record match?
Applicant Name (Manufacturer) :
Prescient Surgical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CleanCision™ Wound Retraction and Protection System is intended for use by a surgeon during abdominal surgery to: retract the surgical incision, provide access to the abdominal cavity, and irrigate the surgical wound edge. The device may aid in the prevention of wound edge contamination. This device is intended to deliver a sterile irrigant solution and serve as a conduit for fluid removal from the surgical wound edge.
Device Description
The CleanCision™ Wound Retraction and Protection System (CleanCision™ System) is a sterile, single-use surgical wound retraction and protection device that integrates surgical retraction, wound barrier protection, and controlled fluid delivery and removal, as shown in Figure 1, below. The wound barrier protection component is comprised of a flexible, doublewalled sheath with an inner layer that may aid in the prevention of wound edge contamination. The wound retraction component is formed by attaching the sheath to a fixed-diameter ring at the bottom, designed to be inserted into the abdominal cavity, and a radially-adjustable upper retraction ring at the top, designed to remain outside of the body and be actuated to achieve wound retraction. The double-walled sheath also includes integrated fluid delivery and removal. Fluid is delivered via gravitational feed from an external sterile irrigation solution bag into the device and delivered to the wound edges through the permeable outer layer of the sheath. Excess fluid is removed through a separate chamber within the sheath via a connection with the hospital's standard vacuum suction mechanism.
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