General, Plastic Surgery— FDA advisory panel SU
16,300 FDA 510(k) clearances across 435 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- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
Top product codes in the General, Plastic Surgery panel
all codes- GEX — Diode Laser Therapy System
- GEI — Potenza Prime
- FXX — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops +1 more
- KGO — Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +1 more
- KKX — BeneHold Surgical Incise Drape with CHG antimicrobial II
- FTL — ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)
- FYA — Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns
- GDW — ETHICON Circular Stapler (CDH21mm) +7 more
- FTC — Phototherapy System (DUV-COMBO)
- GEH — Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)
- OMP — RENASYS DYNAFLOW Kit (66807741)
- FZP — Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips
- GAT — Stitch - Suture Wires and Tapes
- FTM — EluPro Antibiotic-Eluting BioEnvelope
- OHT — Hair Removal Device (R3C16-G Pro, R3C16-V Pro)
Recent clearances in the General, Plastic Surgery panel
all clearances- K262526 — Safety lancet (XL)
- K254185 — Potenza Prime
- K261338 — RENASYS DYNAFLOW Kit (66807741)
- K262007 — PRIMED AAMI Level 3 Open Back Gowns
- K254246 — LT Antibacterial Foam with Silver Dressing
- K261562 — Diode Laser Therapy System
- K262426 — Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)
- K261956 — Dental Barriers and Sleeves (AB0006)
- K254135 — LipoSurg ARTIST
- K262315 — NeuroBlate System
Data sourced from openFDA. This site is unofficial and independent of the FDA.