General, Plastic Surgery— FDA advisory panel SU

16,255 FDA 510(k) clearances across 433 product codes since 1976.

By Andrew Weston — Installation Systems Engineer

This is the classification system's broadest surgical catch-all, which is why it spans more distinct product codes than almost any other panel: electrosurgical generators and their handpieces, surgical lasers, wound dressings, sutures and staplers, surgical mesh, dermal fillers' 510(k)-eligible cousins, liposuction equipment, and a long tail of retractors, forceps, and site-specific instruments that fit no organ-system panel.

Because the panel is defined by exclusion — general surgery plus whatever plastic surgery uses — its product codes are unusually heterogeneous in risk profile, from Class I manual instruments to Class II energy-based systems with substantial special controls. When researching a device here, lean on the product code and regulation number rather than the panel label; two SU devices can have almost nothing in common clinically or technologically.

Clearances per year

last 10 years

Top product codes in the General, Plastic Surgery panel

all codes

Recent clearances in the General, Plastic Surgery panel

all clearances

Data sourced from openFDA. This site is unofficial and independent of the FDA.