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

18201
Total
18157
Cleared
138d
Avg (2y)
1976
Since
4108 General & Plastic Surgery devices
3251–3275 of 4108
Cleared Nov 25, 2015
DERMABOND PRINEO Skin Closure System
K152490 · Ethicon, Inc.
OMD · Cutaneous Tissue Adhesive With Mesh · 85d
Cleared Oct 22, 2015
DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive
K152096 · Ethicon, Inc.
MPN · Tissue Adhesive For The Topical Approximation Of Skin · 86d
Cleared Oct 09, 2015
CLICKLINE Scissor Insert for Single Use
K151044 · KARL STORZ Endoscopy-America, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 172d
Cleared Sep 18, 2015
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
K143743 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 261d
Cleared Sep 17, 2015
KSEA CMOS Camera System (C-cam)
K143640 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 269d
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 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
Cleared Jul 21, 2015
Caiman Seal and Cut Technology
K151858 · Aesculap, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 13d
Cleared Jul 20, 2015
Caiman Seal and Cut Technology
K151696 · Aesculap, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 27d
Cleared Jul 16, 2015
RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device
K151326 · Smith & Nephew, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 59d
Cleared Jul 02, 2015
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
K150670 · Ethicon, Inc.
NEW · Suture, Surgical, Absorbable, Polydioxanone · 108d
Cleared Jun 05, 2015
Phasix ST Mesh
K143380 · C.R. Bard, Inc.
OWT · Mesh, Surgical, Absorbable, Abdominal Hernia · 192d
Cleared Apr 29, 2015
RENASYS
K142979 · Smith & Nephew, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 196d
Cleared Mar 26, 2015
PLIASURE Polyglycolide Synthetic Absorbable Suture
K142822 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 177d
Cleared Mar 25, 2015
Modified ONFLEX Mesh
K142706 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 184d
Cleared Mar 20, 2015
ONFLEX Mesh
K142711 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 179d
Cleared Mar 12, 2015
OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners
K142873 · C.R. Bard, Inc.
GDW · Staple, Implantable · 162d
Cleared Mar 09, 2015
CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners
K142808 · C.R. Bard, Inc.
GDW · Staple, Implantable · 161d
Cleared Dec 15, 2014
ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
K140593 · Cook, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 283d
Cleared Oct 23, 2014
ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE
K141560 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 133d
Cleared Oct 16, 2014
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
K141584 · Boston Scientific Corporation
JCT · Prosthesis, Tracheal, Expandable · 125d
Cleared Oct 15, 2014
STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES
K141776 · Ethicon, Inc.
NEW · Suture, Surgical, Absorbable, Polydioxanone · 105d
Cleared Sep 19, 2014
XENMATRIX AB SURGICAL GRAFT
K133223 · C.R. Bard, Inc.
PIJ · Collagen Surgical Mesh Containing Drugs · 333d
Cleared Sep 04, 2014
CALCULASE II
K140964 · KARL STORZ Endoscopy-America, Inc.
GEX · Powered Laser Surgical Instrument · 142d
Cleared Jul 15, 2014
AESCULAP OPTILENE NONABSORBABLE SUTURE
K133890 · Aesculap, Inc.
GAW · Suture, Nonabsorbable, Synthetic, Polypropylene · 207d

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All categories 4108 GEI Electrosurgical, Cutting & Coagulation & Accessories 539 GEX Powered Laser Surgical Instrument 497 GCJ Laparoscope, General & Plastic Surgery 334 FRO Dressing, Wound, Drug 163 OHT Light Based Over-the-counter Hair Removal 142 OHS Light Based Over The Counter Wrinkle Reduction 118 GDW Staple, Implantable 107 NAY System, Surgical, Computer Controlled Instrument 99 FTL Mesh, Surgical, Polymeric 95 OMP Negative Pressure Wound Therapy Powered Suction Pump 93 KGN Wound Dressing With Animal-derived Material(s) 74 OAP Laser, Comb, Hair 72 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 71 GAM Suture, Absorbable, Synthetic, Polyglycolic Acid 62 GEH Unit, Cryosurgical, Accessories 62