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- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
Top product codes in the General, Plastic Surgery panel
all codes- GEX — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
- GEI — AlphaTriPart - Monopolar MIC Instruments
- FXX — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor
- KGO — Sterile Latex Powder Free Surgical Gloves
- KKX — BeneHold Surgical Incise Drape with CHG antimicrobial II
- FTL — ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)
- FYA — NYES Tuff Cuff L3 Disposable Gowns
- GDW — ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm)
- FTC — Phototherapy System (DUV-COMBO)
- GEH — Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)
- OMP — ConvaVAC Negative Pressure Wound Therapy System
- FZP — Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips
- GAT — EasyWhip Family
- FTM — Endoform Reconstructive Template - PLGA
- OHT — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
Recent clearances in the General, Plastic Surgery panel
all clearances- K260598 — 5 Wavelength LED Facemask (TN2508)
- K261221 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
- K260804 — Anovo Surgical System (6Ne)
- K261179 — AlphaTriPart - Monopolar MIC Instruments
- K262211 — Lancet
- K261738 — Medical Thulium Fiber Laser Systems (UroFiber 150Q)
- K254231 — Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips
- K261693 — Diode laser hair removal machine (QDTM-04)
- K261674 — Skin Air Cooling System (QALF-01)
- K261407 — XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)
Data sourced from openFDA. This site is unofficial and independent of the FDA.