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
13978 General & Plastic Surgery devices
7601–7625 of 13978
Cleared Jul 27, 2004
SMITH & NEPHEW ELECTROBLADE RESECTOR/ADAPTOR
K041328 · Smith & Nephew, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 69d
Cleared Jul 27, 2004
AOC BONE WAX
K041363 · Ceremed , Inc.
MTJ · Wax, Bone · 67d
Cleared Jul 27, 2004
COBRA ADHERE SURGICAL SYSTEM
K041599 · Estech, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 43d
Cleared Jul 23, 2004
L1-PRO SYSTEM
K041665 · Pelikan Technologies, Inc.
FMK · Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature · 35d
Cleared Jul 14, 2004
THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
K040756 · Implex Corp.
FTM · Mesh, Surgical · 112d
Cleared Jul 07, 2004
WATERLASE
K031140 · Biolase Technology, Inc.
GEX · Powered Laser Surgical Instrument · 454d
Cleared Jul 07, 2004
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS
K040237 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 159d
Cleared Jul 07, 2004
ACELL UBM SURGICAL MESH ML AND MLPLUS
K041140 · Acell, Inc.
FTM · Mesh, Surgical · 68d
Cleared Jul 01, 2004
DAVOL DELIVERY SYSTEM
K041641 · C.R. Bard, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 14d
Cleared Jul 01, 2004
ATRICURE DISSECTOR
K041681 · AtriCure, Inc.
FTD · Lamp, Surgical · 10d
Cleared Jun 30, 2004
MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH
K040364 · Porex Surgical, Inc.
FTM · Mesh, Surgical · 138d
Cleared Jun 30, 2004
CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002
K041569 · Curelight, Ltd.
GEX · Powered Laser Surgical Instrument · 20d
Cleared Jun 21, 2004
THERMAGE THERMACOOL SYSTEM
K040135 · Thermage, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 151d
Cleared Jun 15, 2004
RELIANT LASER SYSTEM II
K040617 · Reliant Technologies, Inc.
GEX · Powered Laser Surgical Instrument · 98d
Cleared Jun 15, 2004
BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER
K041331 · Biopsy Sciences, LLC
GDW · Staple, Implantable · 27d
Cleared Jun 14, 2004
STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230
K041383 · Stellartech Research Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 20d
Cleared Jun 09, 2004
HOUVA 3 PHOTOTHERAPY SYSTEM
K041212 · National Biological Corp.
FTC · Light, Ultraviolet, Dermatological · 30d
Cleared Jun 07, 2004
SMITH & NEPHEW ULTRABRAID SUTURE
K041216 · Smith & Nephew, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 28d
Cleared Jun 04, 2004
INNERVUE DIAGNOSTIC SCOPE SYSTEM
K040604 · Arthrotek, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 88d
Cleared Jun 04, 2004
LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)
K040699 · Megadyne Medical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 79d
Cleared Jun 04, 2004
DURABRAID SUTURE
K040789 · Smith & Nephew, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 67d
Cleared Jun 04, 2004
SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH
K040868 · Genzyme Corp.
FTM · Mesh, Surgical · 63d
Cleared Jun 04, 2004
MODIFICATION TO EN-BLOC BIOPSY SYSTEM
K041347 · Neothermia Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 15d
Cleared Jun 03, 2004
SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM
K040720 · Power Medical Interventions, Inc.
GDW · Staple, Implantable · 76d
Cleared Jun 03, 2004
ULTRACLIP II MR
K041201 · Inrad
GDW · Staple, Implantable · 27d

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All categories 13978 GEX Powered Laser Surgical Instrument 2370 GEI Electrosurgical, Cutting & Coagulation & Accessories 1864 GCJ Laparoscope, General & Plastic Surgery 1112 FRO Dressing, Wound, Drug 565 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 256 GEH Unit, Cryosurgical, Accessories 210 OMP Negative Pressure Wound Therapy Powered Suction Pump 209 KGN Wound Dressing With Animal-derived Material(s) 169 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 156 KMF Bandage, Liquid 155