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U.S. Department of Health and Human Services

Product Classification

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Device stapler, surgical
Definition A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.
Physical State A specialized prescription device that delivers compatible staples to internal tissues.
Technical Method A specialized prescription device that delivers compatible staples to internal tissues.
Target Area Internal tissues.
Regulation Medical Specialty General Hospital
Review Panel General & Plastic Surgery
Product CodeGAG
Premarket Review Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.4740
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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