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
7709 General & Plastic Surgery devices
4901–4925 of 7709
Cleared Sep 19, 1997
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
K972679 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 65d
Cleared Sep 19, 1997
MINISITE*BIPOLAR FORCEPS** DEVICE
K972415 · United States Surgical, A Division of Tyco Healthc
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 84d
Cleared Sep 19, 1997
MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER
K972347 · Lumenis, Inc.
GEX · Powered Laser Surgical Instrument · 87d
Cleared Sep 19, 1997
PIONEER ELEC-TROCAR DEVICE
K971728 · Pioneer Surgical Technology
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 133d
Cleared Sep 10, 1997
PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH
K972412 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 76d
Cleared Sep 08, 1997
GRASPING FORCEPS, RIGHT AND LEFT CURVED
K972519 · Richard Wolf Medical Instruments Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 63d
Cleared Aug 27, 1997
THERMOGARD & THERMOGARD PLUS ABC
K972628 · Conmedcorp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 44d
Cleared Aug 27, 1997
KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES
K972497 · KARL STORZ Endoscopy-America, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 55d
Cleared Aug 27, 1997
SHARPLAN EPITOUCH RUBY LASER SYSTEM
K972099 · Sharplan Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 84d
Cleared Aug 27, 1997
CYNOSURE DERMATOLOGY LASER COOLING TIP
K972002 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 89d
Cleared Aug 21, 1997
SHIELDED SURGICAL TROCAR
K971475 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 120d
Cleared Aug 18, 1997
SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)
K971874 · Sharplan Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 90d
Cleared Aug 14, 1997
DEXON VIOLET
K972566 · Davis & Geck, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 36d
Cleared Aug 14, 1997
CONVATEC NON-ADHESIVE DRESSING
K972062 · Convatec, A Division of E.R. Squibb & Sons
KMF · Bandage, Liquid · 72d
Cleared Aug 12, 1997
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES
K971850 · Smith & Nephew, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 84d
Cleared Aug 11, 1997
MVM 3.3 MM MICROENDOSCOPE
K972504 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 39d
Cleared Aug 08, 1997
CYNOSURE PHOTOGENICA LPIR DERMATOLOGICAL LASER
K971737 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 88d
Cleared Aug 07, 1997
ENDOPATH RESPOSABLE TROCAR SYSTEM
K971738 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 87d
Cleared Jul 31, 1997
INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR
K965001 · Intuitive Surgical, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 227d
Cleared Jul 30, 1997
IMPLANTABLE CLIP
K970793 · United States Surgical, A Division of Tyco Healthc
FZP · Clip, Implantable · 148d
Cleared Jul 29, 1997
COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
K971597 · Coloplast Corp.
NAE · Dressing, Wound, Hydrogel Without Drug And/or Biologic · 89d
Cleared Jul 23, 1997
LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES
K971843 · Laserscope
GEX · Powered Laser Surgical Instrument · 70d
Cleared Jul 23, 1997
SHARPLAN ERBIUM: YAG LASER (4020)
K971648 · Sharplan Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 79d
Cleared Jul 23, 1997
ARTHROCARE ELECTROSURGERY SYSTEM
K971532 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 86d
Cleared Jul 18, 1997
SHARPLAN CO2 SURGICAL LASER SYSTEM
K971743 · Sharplan Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 67d

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All categories 7709 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 106 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