General, Plastic Surgery— FDA advisory panel SU
16,354 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 — B`orze Inc Laser Family (Sorren/Adonis)
- GEI — SP Electrocautery Device (SP18 Max); SP Electrocautery Device (SP20 Max)
- 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 — Liora Monofilament Scaffold
- 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 — Tendon Anchor
- FTC — 308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A)
- GEH — Skin Clinic Nitro Clear for Warts and Skin Tags
- OMP — RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257); RENASYS 15Fr Channel Drain Accessory Kit (66802253)
- FZP — Vessel Closure Device (VCD177213P)
- GAT — Stitch - Suture Wires and Tapes
- OHT — IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)
- OHS — Red & Near Infrared LED Light Phototherapy Face Mask (Bway-FM01, Bway-FM02, Bway-FM03, Bway-FM05, Bway-FM06, Bway-FN01, Bway-E01, Bway-E02)
Recent clearances in the General, Plastic Surgery panel
all clearances- K260306 — RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257); RENASYS 15Fr Channel Drain Accessory Kit (66802253)
- K263063 — B`orze Inc Laser Family (Sorren/Adonis)
- K260310 — HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL) +1 more
- K261630 — GI Windows Flexagon Plus OTOLoc System
- K261636 — Microwave Ablation Antennas
- K262343 — Dynavisc
- K260520 — Skin Clinic Nitro Clear for Warts and Skin Tags
- K262349 — Diode laser device (DT25-BI, DT212-BI, DT213-BI, DT214-BI, DT215-BI)
- K263461 — Tendon Anchor
- K262627 — Fractional CO2 Laser Therapy System (Z121)
Data sourced from openFDA. This site is unofficial and independent of the FDA.