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U.S. Department of Health and Human Services

Product Classification

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Device percutaneous surgical set with attachments
Regulation Description Manual percutaneous surgical set assembled in the abdomen.
Definition Minimally invasive devices with the means to penetrate soft tissue to access the abdomen. The attachment and the shaft will be assembled and disassembled within the abdomen before and after use. The devices are used to grasp, hold, and manipulate soft tissues.
Physical State A shaft plus end effector attachments with different sizes
Technical Method A shaft of the device that can penetrate through soft tissue; attachments that will be delivered through a traditional conduit (such as a trocar) and assembled with the shaft inside the abdomen.
Target Area Abdominal region
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOXT
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4805
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible