FDA 510(k) General & Plastic Surgery Devices

FDA 510(k) General & Plastic Surgery Devices - Regulatory Overview

FDA 510(k) general and plastic surgery devices represent the largest 510(k) category with 18,104 submissions since 1976. The FDA review panel code is SU.

This panel covers a broad range of surgical equipment:

• Electrosurgical units (ESU) - monopolar and bipolar cutting and coagulation
• Surgical lasers - CO2, Nd:YAG, diode and excimer surgical lasers
• Laparoscopic instruments - trocars, graspers, staplers, clip appliers
• Wound care and closure - negative pressure therapy, staples, tissue adhesives
• Aesthetic devices - body contouring, skin resurfacing, fat reduction systems