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
13956 General & Plastic Surgery devices
7401–7425 of 13956
Cleared Mar 24, 2005
AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12
K050440 · Ceremed , Inc.
MTJ · Wax, Bone · 30d
Cleared Mar 24, 2005
MEGA POWER ELECTROSURGICAL GENERATOR
K050579 · Megadyne Medical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 17d
Cleared Mar 22, 2005
VANGUARD REPROCESSED ULTRASONIC SCALPEL
K043225 · Vanguard Medical Concepts, Inc.
NLQ · Single-use Reprocessed Ultrasonic Surgical Instruments · 120d
Cleared Mar 22, 2005
VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
K043315 · Vanguard Medical Concepts, Inc.
NLQ · Single-use Reprocessed Ultrasonic Surgical Instruments · 111d
Cleared Mar 18, 2005
OMNILUX REVIVE AND BLUE
K043329 · Photo Therapeutics Limited
GEX · Powered Laser Surgical Instrument · 106d
Cleared Mar 18, 2005
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
K050021 · Vascular Solutions, Inc.
GEX · Powered Laser Surgical Instrument · 72d
Cleared Mar 18, 2005
FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS
K050293 · Fotona D.D.
GEX · Powered Laser Surgical Instrument · 39d
Cleared Mar 14, 2005
SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS
K050108 · Innovaquartz
GEX · Powered Laser Surgical Instrument · 55d
Cleared Mar 14, 2005
LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER
K050344 · Ethicon Endo-Surgery, Inc.
FZP · Clip, Implantable · 31d
Cleared Mar 14, 2005
MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE
K050361 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 28d
Cleared Mar 14, 2005
VAPORMAX
K050412 · Trimedyne, Inc.
GEX · Powered Laser Surgical Instrument · 24d
Cleared Mar 10, 2005
RELIANT LASER II SYSTEM AND ACCESSORIES
K042319 · Reliant Technologies, Inc.
GEX · Powered Laser Surgical Instrument · 196d
Cleared Mar 10, 2005
ENDOLINK TRUE MOVEMENT SYSTEM
K043541 · Novare Surgical Systems, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 78d
Cleared Mar 09, 2005
SHARPOINT LUKENS BONE WAX
K050292 · Surgical Specialties Corp
MTJ · Wax, Bone · 30d
Cleared Mar 09, 2005
SIS FISTULA PLUG
K050337 · Cook Biotech, Inc.
FTM · Mesh, Surgical · 27d
Cleared Mar 09, 2005
MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM
K050364 · Valley Forge Scientific Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 23d
Cleared Mar 09, 2005
AURORA SR AND SRA APPLICATOR
K050452 · Syneron Medical, Ltd.
GEX · Powered Laser Surgical Instrument · 15d
Cleared Mar 04, 2005
FEATHERLIFT EXTENDED APTOS THREAD
K043591 · Kmi Kolster Methods, Inc.
GAW · Suture, Nonabsorbable, Synthetic, Polypropylene · 66d
Cleared Mar 04, 2005
CONTOUR NECKLIFT THREADS
K050247 · Surgical Specialties Corp
GAW · Suture, Nonabsorbable, Synthetic, Polypropylene · 30d
Cleared Mar 03, 2005
MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
K043288 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 94d
Cleared Mar 03, 2005
PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01
K043486 · Topcon Medical Laser Systems, Inc.
GEX · Powered Laser Surgical Instrument · 76d
Cleared Mar 02, 2005
GYRUS PLASMA SKIN RESURFACING SYSTEM
K041999 · Gyrus Medical, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 219d
Cleared Mar 02, 2005
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR
K043133 · Ceremed , Inc.
KKY · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction · 110d
Cleared Feb 25, 2005
ENDOASSIST
K043284 · Armstrong Healthcare Limited
GCJ · Laparoscope, General & Plastic Surgery · 91d
Cleared Feb 24, 2005
ELLIPSE LIGHT SPT
K043255 · Danish Dermatologic Development A/S
GEX · Powered Laser Surgical Instrument · 92d

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All categories 13956 GEX Powered Laser Surgical Instrument 2368 GEI Electrosurgical, Cutting & Coagulation & Accessories 1860 GCJ Laparoscope, General & Plastic Surgery 1109 FRO Dressing, Wound, Drug 563 FTL Mesh, Surgical, Polymeric 315 GDW Staple, Implantable 255 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 155 KMF Bandage, Liquid 155