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

18256
Total
18211
Cleared
137d
Avg (2y)
1976
Since
7701 General & Plastic Surgery devices
4601–4625 of 7701
Cleared Dec 20, 2000
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
K003100 · Boston Scientific Corp
JCT · Prosthesis, Tracheal, Expandable · 78d
Cleared Dec 20, 2000
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210
K002308 · Trimedyne, Inc.
GEX · Powered Laser Surgical Instrument · 145d
Cleared Dec 15, 2000
LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)
K003147 · Laserscope
GEX · Powered Laser Surgical Instrument · 66d
Cleared Dec 15, 2000
ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07
K002906 · Ethicon Endo-Surgery, Inc.
LFL · Instrument, Ultrasonic Surgical · 88d
Cleared Dec 08, 2000
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K001895 · United States Surgical, A Division of Tyco Healthc
GDW · Staple, Implantable · 170d
Cleared Dec 04, 2000
CLEARGLIDE PRECISION BIPOLAR DEVICE
K003587 · Ethicon, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 13d
Cleared Dec 04, 2000
REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE
K002987 · Xomed, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 70d
Cleared Nov 29, 2000
AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
K002721 · American Medical Systems, Inc.
FTL · Mesh, Surgical, Polymeric · 90d
Cleared Nov 24, 2000
IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
K002886 · Implantech Associates, Inc.
LZK · Implant, Malar · 70d
Cleared Nov 22, 2000
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
K002672 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 86d
Cleared Nov 03, 2000
3D ENDOSCOPE
K002924 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 45d
Cleared Nov 03, 2000
CANDELA MID IR DIODE LASER SYSTEM
K002421 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 87d
Cleared Nov 02, 2000
OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A
K001676 · Trimedyne, Inc.
GEX · Powered Laser Surgical Instrument · 154d
Cleared Oct 23, 2000
MR-III
K002261 · Smith & Nephew, Inc.
GAS · Suture, Nonabsorbable, Synthetic, Polyester · 90d
Cleared Oct 11, 2000
COMPOSIX E/X MESH
K002684 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 44d
Cleared Sep 19, 2000
CANDELA SPTL-1B PULSED DYE LASER
K001093 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 168d
Cleared Aug 24, 2000
MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
K001666 · Intuitive Surgical, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 85d
Cleared Aug 18, 2000
CANDELA DYNAMIC COOLING DEVICE
K001589 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 87d
Cleared Aug 17, 2000
SUREFIT DISPERSIVE ELECTRODE
K002002 · Conmedcorp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 48d
Cleared Jul 27, 2000
EPI-STAR SURGICAL LASER SYSTER
K990119 · Nidek, Inc.
GEX · Powered Laser Surgical Instrument · 561d
Cleared Jul 24, 2000
ATRIUM LITE MESH
K002093 · Atrium Medical Corp.
FTL · Mesh, Surgical, Polymeric · 13d
Cleared Jul 19, 2000
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD
K001936 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 23d
Cleared Jul 18, 2000
AUTO SUTURE MICRO SURGICLIP CLIP APPLIER
K001450 · United States Surgical, A Division of Tyco Healthc
FZP · Clip, Implantable · 71d
Cleared Jul 17, 2000
ARTHROCARE FLOW CONTROL UNIT
K001904 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 25d
Cleared Jul 11, 2000
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
K990144 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 539d

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All categories 7701 GEX Powered Laser Surgical Instrument 1148 GEI Electrosurgical, Cutting & Coagulation & Accessories 1108 GCJ Laparoscope, General & Plastic Surgery 682 FRO Dressing, Wound, Drug 222 FTL Mesh, Surgical, Polymeric 186 GDW Staple, Implantable 159 NAY System, Surgical, Computer Controlled Instrument 158 OHT Light Based Over-the-counter Hair Removal 142 OHS Light Based Over The Counter Wrinkle Reduction 120 OMP Negative Pressure Wound Therapy Powered Suction Pump 103 FZP Clip, Implantable 100 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 93 KGN Wound Dressing With Animal-derived Material(s) 85 LFL Instrument, Ultrasonic Surgical 85 GEH Unit, Cryosurgical, Accessories 78