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
4109 General & Plastic Surgery devices
3401–3425 of 4109
Cleared Jul 27, 2006
KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR
K061180 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 91d
Cleared Jul 19, 2006
OPTILENE MESH
K061704 · Aesculap, Inc.
FTL · Mesh, Surgical, Polymeric · 33d
Cleared Jul 14, 2006
SYNERGY HIP SYSTEM
K061066 · Smith & Nephew, Inc.
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 88d
Cleared Jul 14, 2006
PDS PLUS ANTIBACTERIAL SUTURE
K061037 · Ethicon, Inc.
NEW · Suture, Surgical, Absorbable, Polydioxanone · 91d
Cleared Jun 19, 2006
MEDLINE COLLAGEN WOUND DRESSING
K060456 · Medline Industries, Inc.
KGN · Wound Dressing With Animal-derived Material(s) · 117d
Cleared Jun 19, 2006
3M LIQUID BANDAGE
K053409 · 3M Company
KMF · Bandage, Liquid · 194d
Cleared May 31, 2006
AUTO SUTUR ENDO GIA STAPLERS
K061095 · United States Surgical, A Division of Tyco Healthc
GDW · Staple, Implantable · 42d
Cleared May 25, 2006
PROCEED SURGICAL MESH
K060713 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 69d
Cleared Apr 13, 2006
SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM
K060777 · Smith & Nephew, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 22d
Cleared Apr 10, 2006
BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105
K052322 · C.R. Bard, Inc.
FTM · Mesh, Surgical · 228d
Cleared Mar 28, 2006
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
K060528 · Aesculap, Inc.
GAR · Suture, Nonabsorbable, Synthetic, Polyamide · 28d
Cleared Mar 13, 2006
CONCERTO BIPOLAR NEEDLE ELECTRODE
K060419 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 24d
Cleared Mar 06, 2006
NUVANCE* FACIAL REJUVENATION SYSTEM
K052953 · Ethicon, Inc.
MXW · Suture, Surgical, Nonabsorbable, Poly (vinylidene Fluoride) · 137d
Cleared Feb 28, 2006
CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000
K060400 · Medtronic, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 13d
Cleared Jan 23, 2006
CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES
K052680 · KARL STORZ Endoscopy-America, Inc.
GEX · Powered Laser Surgical Instrument · 117d
Cleared Jan 18, 2006
OPTILENE MESH LP
K053158 · Aesculap, Inc.
FTL · Mesh, Surgical, Polymeric · 65d
Cleared Dec 16, 2005
3M TEGADERM SILVER (AG) MESH
K053256 · 3M Company
FRO · Dressing, Wound, Drug · 24d
Cleared Dec 16, 2005
U-CLIP DEVICE, MODELS B140, B160 AND B180
K053252 · Medtronic Vascular
FZP · Clip, Implantable · 25d
Cleared Nov 30, 2005
SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE
K053128 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 22d
Cleared Nov 23, 2005
SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM
K050209 · Smith & Nephew, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 299d
Cleared Oct 21, 2005
SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE
K052652 · Smith & Nephew, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 25d
Cleared Oct 20, 2005
MEDLINE IODOFORM PACKING STRIPS
K052720 · Medline Industries, Inc.
FRO · Dressing, Wound, Drug · 21d
Cleared Oct 20, 2005
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
K052155 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 73d
Cleared Oct 05, 2005
SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS
K051879 · Synthes (Usa)
FTM · Mesh, Surgical · 86d
Cleared Sep 29, 2005
VICRYL * MESH BAG
K051701 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 97d

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All categories 4109 GEI Electrosurgical, Cutting & Coagulation & Accessories 539 GEX Powered Laser Surgical Instrument 498 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