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
13991 General & Plastic Surgery devices
7676–7700 of 13991
Cleared Feb 25, 2004
COLORADO MICRODISSECTION NEEDLE
K033232 · Stryker Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 142d
Cleared Feb 25, 2004
SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975
K033981 · Smith & Nephew, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 64d
Cleared Feb 24, 2004
COBRA SURGICAL PROBE
K040219 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 22d
Cleared Feb 18, 2004
SIS PLASTIC SURGERY MATRIX
K034039 · Cook Biotech, Inc.
FTM · Mesh, Surgical · 51d
Cleared Feb 18, 2004
COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0
K040104 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 29d
Cleared Feb 12, 2004
MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE
K033718 · Arthrotek, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 78d
Cleared Feb 12, 2004
VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC
K040118 · Vascular Solutions, Inc.
QSX · Hemostatic Wound Dressing With Thrombin Or Other Biologics · 23d
Cleared Feb 09, 2004
APOGEE ELITE
K034030 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 42d
Cleared Feb 05, 2004
HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM
K033089 · Gyrus Ent LLC
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 129d
Cleared Feb 04, 2004
MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT
K033652 · Zimmer, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 76d
Cleared Feb 04, 2004
THERMAGE THERMACOOL SYSTEM
K033942 · Thermage, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 47d
Cleared Feb 04, 2004
SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29
K040024 · Power Medical Interventions, Inc.
GDW · Staple, Implantable · 28d
Cleared Feb 04, 2004
CURVED CUTTER STAPLER, MODELS CS40B, CS40G
K040038 · Ethicon Endo-Surgery, Inc.
GDW · Staple, Implantable · 27d
Cleared Jan 30, 2004
WATERLASE
K030523 · Biolase Technology, Inc.
GEX · Powered Laser Surgical Instrument · 345d
Cleared Jan 28, 2004
CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376
K033447 · Mri Devices Corp.
NEU · Marker, Radiographic, Implantable · 91d
Cleared Jan 27, 2004
AC APPLICATOR, AURORA AC
K032514 · Syneron Medical, Ltd.
GEX · Powered Laser Surgical Instrument · 166d
Cleared Jan 21, 2004
TRISTAR AESTHETIC WORKSTATION LASER
K033176 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 112d
Cleared Jan 16, 2004
CANDELA CBEAM PULSE DYE LASER SYSTEM
K033331 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 92d
Cleared Jan 16, 2004
CANDELA VBEAM PULSE DYE LASER SYSTEM
K033461 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 78d
Cleared Jan 15, 2004
UGYTEX MESH
K033376 · Sofradim Production
FTL · Mesh, Surgical, Polymeric · 85d
Cleared Jan 15, 2004
FORCE FIBER
K033654 · Teleflex Medical
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 55d
Cleared Jan 14, 2004
ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239
K032245 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 176d
Cleared Dec 31, 2003
GORE BIOABSORBABLE MESH
K033671 · W.L. Gore & Associates, Inc.
OWT · Mesh, Surgical, Absorbable, Abdominal Hernia · 37d
Cleared Dec 18, 2003
REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS
K032973 · Vanguard Medical Concepts, Inc.
GDW · Staple, Implantable · 85d
Cleared Dec 18, 2003
AMI REPROCESSED MULTIPLE CLIP APPLIERS
K032980 · Vanguard Medical Concepts, Inc.
FZP · Clip, Implantable · 85d

Looking for a specific general & plastic surgery device? Search by device name, K-number or manufacturer.

Search all General & Plastic Surgery 510(k) devices

Filter by Product Code

All categories 13991 GEX Powered Laser Surgical Instrument 2370 GEI Electrosurgical, Cutting & Coagulation & Accessories 1867 GCJ Laparoscope, General & Plastic Surgery 1113 FRO Dressing, Wound, Drug 568 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) 170 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 157 KMF Bandage, Liquid 155