Product Classification

• 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 Code: GAG
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); 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

Guidance Document

• Surgical Staplers and Staples for Internal Use - Labeling Recommendations: Guidance for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible