510(k) General & Plastic Surgery Devices

FDA 510(k) Cleared General & Plastic Surgery Devices

This page lists all 18104 medical devices in the General & Plastic Surgery specialty that have been submitted to the FDA through the 510(k) premarket notification process. Surgical lasers, electrosurgical units, laparoscopic tools and wound care devices.

• 18061 devices cleared as substantially equivalent to a predicate device.
• Average time to FDA decision: 114 days.
• Records available from 1976 to the present.
• Filter by product code using the sidebar to narrow results by device type.