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
14008 General & Plastic Surgery devices
8026–8050 of 14008
Cleared Feb 15, 2002
CANDELA SMOOTHBEAM LASER SYSTEM
K013825 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 88d
Cleared Feb 14, 2002
MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030.
K014036 · Medtrade Products , Ltd.
MDA · Elastomer, Silicone, For Scar Management · 69d
Cleared Feb 12, 2002
RUSCH MEMORY BAG
K013872 · Rusch Intl.
GCJ · Laparoscope, General & Plastic Surgery · 83d
Cleared Feb 12, 2002
BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230
K013904 · Baylis Medical Co., Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 78d
Cleared Feb 11, 2002
CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)
K013748 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 90d
Cleared Feb 11, 2002
ENDOANCHOR AND OPENANCHOR
K013749 · Ethicon Endo-Surgery, Inc.
GDW · Staple, Implantable · 90d
Cleared Feb 08, 2002
MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60
K013864 · Nidek, Inc.
GEX · Powered Laser Surgical Instrument · 79d
Cleared Feb 07, 2002
GELZONE
K013732 · Implantech Associates, Inc.
MDA · Elastomer, Silicone, For Scar Management · 90d
Cleared Feb 07, 2002
SMARTEPIL
K020107 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 27d
Cleared Feb 01, 2002
DYONICS ELECTROBLADE RESECTOR
K012314 · Smith & Nephew, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 193d
Cleared Jan 31, 2002
NUCLEOTOMY INTRADISCAL CATHETER
K013622 · Oratec Interventions, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 87d
Cleared Jan 31, 2002
MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX
K020077 · Augustine Medical, Inc.
MSA · Dressing, Wound And Burn, Occlusive, Heated · 22d
Cleared Jan 30, 2002
LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS
K013617 · Olympus Optical Co., Ltd.
GCJ · Laparoscope, General & Plastic Surgery · 86d
Cleared Jan 29, 2002
SEEDNET, MODEL FP6T5, FP5T5, FP5T3
K011950 · Galil Medical , Ltd.
GEH · Unit, Cryosurgical, Accessories · 222d
Cleared Jan 29, 2002
THERMAGE THERMACOOL TC SYSTEM
K013639 · Thermage, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 85d
Cleared Jan 29, 2002
SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS
K013641 · Senorx, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 85d
Cleared Jan 28, 2002
SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED
K014021 · Surgical Specialties Corp
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 53d
Cleared Jan 25, 2002
CRYOCARE SURGICAL SYSTEM
K011074 · Endocare, Inc.
GEH · Unit, Cryosurgical, Accessories · 291d
Cleared Jan 25, 2002
PERICSCOPE, MODEL # PERISC1
K013576 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 88d
Cleared Jan 18, 2002
VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT
K012293 · Vascular Solutions, Inc.
QSX · Hemostatic Wound Dressing With Thrombin Or Other Biologics · 182d
Cleared Jan 18, 2002
REPROCESSED ELECTROSURGICAL ELECTRODE
K012684 · Sterilmed, Inc.
JOS · Electrode, Electrosurgical · 157d
Cleared Jan 18, 2002
ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD
K014222 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 23d
Cleared Jan 17, 2002
DILATING TIP OBTURATOR
K012884 · Applied Medical Resources Corp.
GCJ · Laparoscope, General & Plastic Surgery · 142d
Cleared Jan 17, 2002
SELF-DRILLING RADIOGRAPHIC MARKER
K014148 · Walter Lorenz Surgical, Inc.
NEU · Marker, Radiographic, Implantable · 30d
Cleared Jan 10, 2002
LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC, 1 CCD CAMERA HEAD PAL, LIGHT PROJECTOR, MODEL 5551.107
K010033 · Richard Wolf Medical Instruments Corp.
GCJ · Laparoscope, General & Plastic Surgery · 371d

Looking for a specific general & plastic surgery device? Search by device name, K-number or manufacturer.

Search all General & Plastic Surgery 510(k) devices

Filter by Product Code

All categories 14008 GEX Powered Laser Surgical Instrument 2372 GEI Electrosurgical, Cutting & Coagulation & Accessories 1869 GCJ Laparoscope, General & Plastic Surgery 1113 FRO Dressing, Wound, Drug 572 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 257 OMP Negative Pressure Wound Therapy Powered Suction Pump 211 GEH Unit, Cryosurgical, Accessories 210 KGN Wound Dressing With Animal-derived Material(s) 171 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