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U.S. Department of Health and Human Services

Product Classification

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Device mesh, surgical, deployment balloon
Regulation Description Surgical mesh.
Definition The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias.
Physical State The device is comprised of three main components: an inflatable spreading balloon, an adaptor, and an inflation unit/pump.
Technical Method The device is reversibly attached to soft tissue prosthetics, such as surgical mesh, through the use of connectors, before being rolled for insertion into the body. Once located in the abdominal cavity, the device is spread at the desired location by inflating it using an external inflation pump.
Target Area Abdominal cavity.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOQL
Premarket Review Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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