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U.S. Department of Health and Human Services

Product Classification

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Device wound retraction and protection system
Definition A prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound.
Physical State The device is comprised of a flexible, double-walled sheath with an impermeable inner layer. The retraction component is formed by attaching the sheath to a fixed-diameter ring at the bottom of the device. The sheath also includes an integrated fluid delivery and removal component.
Technical Method The device is sterile, single-use surgical wound retraction that integrates surgical retraction, wound barrier protection, and 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.
Target Area Abdomen
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePQI
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 878.4371
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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