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
14028 General & Plastic Surgery devices
8351–8375 of 14028
Cleared Feb 10, 2000
ULTRABLATOR ELECTRODE
K993885 · Linvatec Corp.
JOS · Electrode, Electrosurgical · 86d
Cleared Feb 09, 2000
POLYGLYCOLIC ACID
K994001 · Trading Consultants and Distributors Intl., Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 77d
Cleared Feb 08, 2000
SUTRALON NYLON SUTURES
K994176 · Visionary Medical Supplies, Inc.
GAR · Suture, Nonabsorbable, Synthetic, Polyamide · 60d
Cleared Feb 08, 2000
SUTRASILK SILK SUTURE
K994177 · Visionary Medical Supplies, Inc.
GAP · Suture, Nonabsorbable, Silk · 60d
Cleared Feb 08, 2000
FRONTAL SINUS TREPHINATION CANNULA
K994262 · Xomed, Inc.
KAM · Cannula, Sinus · 53d
Cleared Feb 08, 2000
BITX PROBES
K994336 · Everest Medical Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 47d
Cleared Feb 04, 2000
ENTEC REFLEX WAND 55, MODEL E4055-00
K000036 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 29d
Cleared Feb 04, 2000
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA SCALPEL GS, TURBOVAC GS
K000074 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 24d
Cleared Feb 04, 2000
ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)
K992805 · Oratec Interventions, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 168d
Cleared Feb 04, 2000
ULTRACLIP TISSUE MARKER
K993785 · Inrad
GDW · Staple, Implantable · 88d
Cleared Feb 04, 2000
SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C
K993834 · Cardiofocus, Inc.
GEX · Powered Laser Surgical Instrument · 84d
Cleared Feb 04, 2000
POLYPROPYLENE
K993997 · Trading Consultants and Distributors Intl., Inc.
GAW · Suture, Nonabsorbable, Synthetic, Polypropylene · 72d
Cleared Feb 04, 2000
NYLON
K993998 · Trading Consultants and Distributors Intl., Inc.
GAR · Suture, Nonabsorbable, Synthetic, Polyamide · 72d
Cleared Feb 04, 2000
SILK
K993999 · Trading Consultants and Distributors Intl., Inc.
GAP · Suture, Nonabsorbable, Silk · 72d
Cleared Feb 04, 2000
POLYESTER
K994000 · Trading Consultants and Distributors Intl., Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 72d
Cleared Feb 04, 2000
PLAIN/CHROMIC CATGUT
K994002 · Trading Consultants and Distributors Intl., Inc.
GAL · Suture, Absorbable, Natural · 72d
Cleared Feb 04, 2000
COALESCENT SURGICAL SUTURED-CLIP
K994160 · Coalescent Surgical
FZP · Clip, Implantable · 57d
Cleared Feb 03, 2000
SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823
K994256 · A & A Medical, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 48d
Cleared Feb 01, 2000
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINEWANDS
K000044 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 25d
Cleared Feb 01, 2000
CERALAS D10 810NM DIODE LASER
K993828 · Ceram Optec, Inc.
GEX · Powered Laser Surgical Instrument · 81d
Cleared Feb 01, 2000
CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50
K993911 · Ceram Optec, Inc.
GEX · Powered Laser Surgical Instrument · 77d
Cleared Jan 31, 2000
KERLIX MD ANTIMICROBIAL GAUZE DRESSING
K990530 · The Kendall Company, L.P.
NAD · Dressing, Wound, Occlusive · 346d
Cleared Jan 27, 2000
EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM
K991935 · Esc Medical Systems , Ltd.
GEX · Powered Laser Surgical Instrument · 232d
Cleared Jan 27, 2000
ELECTROSURGICAL ELECTRODE FAMILY
K992045 · Genesis Medical, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 224d
Cleared Jan 27, 2000
EXCIMER LASER PHOTOTHERAPY SYSTEM, AL7000
K992914 · Acculase, Inc.
GEX · Powered Laser Surgical Instrument · 150d

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All categories 14028 GEX Powered Laser Surgical Instrument 2373 GEI Electrosurgical, Cutting & Coagulation & Accessories 1873 GCJ Laparoscope, General & Plastic Surgery 1114 FRO Dressing, Wound, Drug 574 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 258 OMP Negative Pressure Wound Therapy Powered Suction Pump 211 GEH Unit, Cryosurgical, Accessories 211 KGN Wound Dressing With Animal-derived Material(s) 171 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 161 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 158 EFQ Gauze/sponge, Internal 157 KMF Bandage, Liquid 155