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
3476–3500 of 4109
Cleared May 22, 2003
DYONICS VISION 325Z DV3-CCD HERMES READY CAMERA SYSTEM, MODEL 7209531
K031379 · Smith & Nephew, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 21d
Cleared May 15, 2003
BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH
K031332 · C.R. Bard, Inc.
FTM · Mesh, Surgical · 17d
Cleared Mar 14, 2003
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K024275 · United States Surgical, A Division of Tyco Healthc
GDW · Staple, Implantable · 81d
Cleared Feb 20, 2003
SMALL BARD VENTRALEX PATCH
K024008 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 78d
Cleared Jan 30, 2003
KSEA SCB ACC CONTROL
K023704 · KARL STORZ Endoscopy-America, Inc.
FTA · Light, Surgical, Accessories · 87d
Cleared Dec 19, 2002
STEELEX STERNUM SET
K023411 · Aesculap, Inc.
GAQ · Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile · 69d
Cleared Dec 19, 2002
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE
K022715 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 126d
Cleared Dec 17, 2002
ARTHREX OPES ELECTRODES AND ACCESSORIES
K023986 · Arthrex, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 15d
Cleared Nov 19, 2002
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K020804 · United States Surgical, A Division of Tyco Healthc
GDW · Staple, Implantable · 252d
Cleared Nov 13, 2002
MICROVASIVE PULMONARY GUIDEWIRE
K022059 · Boston Scientific Corp
MDM · Instrument, Manual, Surgical, General Use · 141d
Cleared Nov 07, 2002
ARTHREX FIBERWIRE IN USP SIZES
K021434 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 185d
Cleared Nov 04, 2002
AUTOCON II 400 ELECTROSURGICAL GENERATOR
K021467 · KARL STORZ Endoscopy-America, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 181d
Cleared Oct 17, 2002
COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X
K023291 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 15d
Cleared Oct 03, 2002
DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
K023053 · Smith & Nephew, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 20d
Cleared Sep 13, 2002
COATED VICRYL* (POLYGLACTIN 910) SUTURE
K022269 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 60d
Cleared Aug 28, 2002
PRECISION PLUS TUNA OFFICE SYSTEM
K021804 · Medtronic Vascular
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 86d
Cleared Aug 23, 2002
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
K022350 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 35d
Cleared Jul 16, 2002
BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301
K021736 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 49d
Cleared Jul 11, 2002
COBRA CARDIAC ELECTROSURGICAL SYSTEM
K013873 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 232d
Cleared May 28, 2002
KSEA SCB MEDIA CONTROL
K020640 · KARL STORZ Endoscopy-America, Inc.
FTA · Light, Surgical, Accessories · 90d
Cleared Apr 16, 2002
COBRA COOLED SURGICAL PROBE, MODEL 1596X
K021046 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 15d
Cleared Mar 21, 2002
REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083
K014207 · Aesculap, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 90d
Cleared Mar 19, 2002
NELSON ELECTROSURGICAL UNIT, MODEL GN640
K014172 · Aesculap, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 89d
Cleared Mar 12, 2002
RBM
K020480 · Smith & Nephew, Inc.
KGS · Retention Device, Suture · 27d
Cleared Feb 01, 2002
DYONICS ELECTROBLADE RESECTOR
K012314 · Smith & Nephew, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 193d

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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