FDA Review Panel · SU

FDA 510(k) General & Plastic Surgery Devices

FDA 510(k) General & Plastic Surgery Devices - Regulatory Overview

FDA 510(k) general and plastic surgery devices represent the largest 510(k) category with 18,104 submissions since 1976. The FDA review panel code is SU.

This panel covers a broad range of surgical equipment:

  • Electrosurgical units (ESU) - monopolar and bipolar cutting and coagulation
  • Surgical lasers - CO2, Nd:YAG, diode and excimer surgical lasers
  • Laparoscopic instruments - trocars, graspers, staplers, clip appliers
  • Wound care and closure - negative pressure therapy, staples, tissue adhesives
  • Aesthetic devices - body contouring, skin resurfacing, fat reduction systems

18288
Total
18243
Cleared
138d
Avg (2y)
1976
Since
13998 General & Plastic Surgery devices
7751–7775 of 13998
Cleared Oct 01, 2003
SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER
K031440 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 148d
Cleared Oct 01, 2003
MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
K032805 · Vascular Solutions, Inc.
GEX · Powered Laser Surgical Instrument · 22d
Cleared Sep 30, 2003
SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)
K032701 · Power Medical Interventions, Inc.
GDW · Staple, Implantable · 28d
Cleared Sep 29, 2003
DRESSSKIN
K023778 · Tei Biosciences, Inc.
KGN · Wound Dressing With Animal-derived Material(s) · 321d
Cleared Sep 26, 2003
SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045
K032680 · Smith & Nephew, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 28d
Cleared Sep 23, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K031305 · Olympus Optical Co., Ltd.
LFL · Instrument, Ultrasonic Surgical · 152d
Cleared Sep 22, 2003
MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET
K031955 · Macropore Biosurgery, Inc.
FTL · Mesh, Surgical, Polymeric · 89d
Cleared Sep 17, 2003
D-STAT-DRY HEMOSTATIC BANDAGE
K030836 · Vascular Solutions, Inc.
QSX · Hemostatic Wound Dressing With Thrombin Or Other Biologics · 184d
Cleared Sep 17, 2003
PROCEED TRILAMINATE SURGICAL MESH
K031925 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 86d
Cleared Sep 16, 2003
CANDELA SMOOTHBEAM LASER SYSTEM
K030846 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 183d
Cleared Sep 16, 2003
SOPRO 61D
K031593 · Sopro
GCJ · Laparoscope, General & Plastic Surgery · 118d
Cleared Sep 11, 2003
TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6
K031951 · Baylis Medical Co., Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 79d
Cleared Sep 05, 2003
ENDOSCOPIC APPLICATOR
K031882 · Baxter Healthcare Corp
GCJ · Laparoscope, General & Plastic Surgery · 79d
Cleared Sep 05, 2003
GEL MARK III BIOPSY SITE MARKER
K031938 · Senorx, Inc.
NEU · Marker, Radiographic, Implantable · 74d
Cleared Aug 22, 2003
MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS
K022587 · Medtrade Products , Ltd.
MGQ · Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic · 382d
Cleared Aug 21, 2003
COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS
K031954 · New Star Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 57d
Cleared Aug 21, 2003
MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
K032282 · Implex Corp.
EZX · Mesh, Surgical, Metal · 28d
Cleared Aug 21, 2003
BIOMARC TISSUE MARKER
K032347 · Carbon Medical Technologies, Inc.
GDW · Staple, Implantable · 22d
Cleared Aug 21, 2003
ARTHROCARE SYSTEM
K032504 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 8d
Cleared Aug 20, 2003
MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
K032204 · Vascular Solutions, Inc.
GEX · Powered Laser Surgical Instrument · 33d
Cleared Aug 20, 2003
COBRA COOLED SURGICAL PROBE, MODEL M004159670
K032207 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 33d
Cleared Aug 19, 2003
PITANGA
K031489 · Syneron Medical, Ltd.
GEX · Powered Laser Surgical Instrument · 99d
Cleared Aug 15, 2003
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL
K032168 · W.L. Gore & Associates, Inc.
FTL · Mesh, Surgical, Polymeric · 30d
Cleared Aug 12, 2003
STRYKER VISUM SURGICAL LIGHTING SYSTEM
K031068 · Stryker Endoscopy
FSY · Light, Surgical, Ceiling Mounted · 130d
Cleared Aug 08, 2003
CARDIOVATIONS PORTABLE VIDEO SYSTEM
K032339 · Ethicon, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 10d

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All categories 13998 GEX Powered Laser Surgical Instrument 2370 GEI Electrosurgical, Cutting & Coagulation & Accessories 1869 GCJ Laparoscope, General & Plastic Surgery 1113 FRO Dressing, Wound, Drug 569 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 257 OMP Negative Pressure Wound Therapy Powered Suction Pump 210 GEH Unit, Cryosurgical, Accessories 210 KGN Wound Dressing With Animal-derived Material(s) 170 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 159 EFQ Gauze/sponge, Internal 157 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 157 KMF Bandage, Liquid 155