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U.S. Department of Health and Human Services

Product Classification
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Device stapler, surgical
Regulation Description Surgical stapler.
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 Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Infection Control and Plastic and Reconstructive 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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