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
13712 General & Plastic Surgery devices
4176–4200 of 13712
Cleared Aug 20, 2015
PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,
K141017 · Kci USA, Inc. (Kinetic Concepts, Inc.)
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 486d
Cleared Aug 19, 2015
Cook ECM Powder
K152033 · Cook Biotech Incorporated
KGN · Wound Dressing With Animal-derived Material(s) · 28d
Cleared Aug 19, 2015
TraceIT Tissue Marker - 3mL
K151998 · Augmenix, Inc.
NEU · Marker, Radiographic, Implantable · 30d
Cleared Aug 18, 2015
Nexus Suture
K151009 · Baylis Medical Company, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 125d
Cleared Aug 14, 2015
Wartie Advanced Wart Remover or other proprietary name
K151309 · Youmedical Corp BV
GEH · Unit, Cryosurgical, Accessories · 88d
Cleared Aug 13, 2015
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
K151200 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 100d
Cleared Aug 13, 2015
Stryker Suture Tape
K150584 · Stryker
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 157d
Cleared Aug 12, 2015
LightSheer Desire Light Laser System
K151947 · Lumenis, Ltd.
GEX · Powered Laser Surgical Instrument · 28d
Cleared Aug 10, 2015
Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar
K141594 · Unimicro Medical Systems (Shenzhen) Co., Ltd.
GCJ · Laparoscope, General & Plastic Surgery · 423d
Cleared Aug 07, 2015
Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver
K143017 · Laboratoires Urgo
FRO · Dressing, Wound, Drug · 291d
Cleared Aug 07, 2015
LEECH, MEDICINAL
K140907 · Carolina Biological Supply Co.
NRN · Leeches, Medicinal · 486d
Cleared Aug 06, 2015
VIKINI Diode Laser System
K151232 · Ilooda Co,., Ltd.
GEX · Powered Laser Surgical Instrument · 90d
Cleared Aug 05, 2015
OPTIS Integrated System Mobile Workstation
K151286 · Lightlab Imaging, Inc.
NQQ · System, Imaging, Optical Coherence Tomography (oct) · 83d
Cleared Aug 04, 2015
Bovie J-Plasma Handpiece
K151325 · Bovie Medical Corporation
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 78d
Cleared Aug 04, 2015
Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot
K150735 · Covidien
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 137d
Cleared Aug 04, 2015
Venus Legacy CX
K143554 · Venus Concept , Ltd.
PBX · Massager, Vacuum, Radio Frequency Induced Heat · 232d
Cleared Jul 31, 2015
HEMO-Bandage
K151204 · Coreleader Biotech Co., Ltd.
QSY · Hemostatic Wound Dressing Without Thrombin Or Other Biologics · 87d
Cleared Jul 31, 2015
GME ExSys 308
K150752 · Gme (German Medical Engineering) GmbH
FTC · Light, Ultraviolet, Dermatological · 130d
Cleared Jul 30, 2015
XenMatrix AB Surgical Graft
K151177 · C. R. Bard
PIJ · Collagen Surgical Mesh Containing Drugs · 90d
Cleared Jul 29, 2015
Cellfina System
K150505 · Ulthera, Inc.
OUP · Powered Surgical Instrument For Improvement In The Appearance Of Cellulite · 154d
Cleared Jul 29, 2015
Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor
K150377 · Sony Electronics, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 166d
Cleared Jul 28, 2015
Barrx Anorectal RFA Wand
K150251 · Covidien, LLC
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 175d
Cleared Jul 27, 2015
A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device
K150924 · Anchor Innovation Medical (A.I.M.)
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 112d
Cleared Jul 24, 2015
ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh
K150906 · Ehicon, Inc.
FTL · Mesh, Surgical, Polymeric · 112d
Cleared Jul 23, 2015
RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device
K143133 · Smith & Nephew, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 265d

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All categories 13712 GEX Powered Laser Surgical Instrument 2338 GEI Electrosurgical, Cutting & Coagulation & Accessories 1832 GCJ Laparoscope, General & Plastic Surgery 1083 FRO Dressing, Wound, Drug 528 FTL Mesh, Surgical, Polymeric 305 GDW Staple, Implantable 249 GEH Unit, Cryosurgical, Accessories 208 OMP Negative Pressure Wound Therapy Powered Suction Pump 205 KGN Wound Dressing With Animal-derived Material(s) 163 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 158 EFQ Gauze/sponge, Internal 157 KMF Bandage, Liquid 153 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 147