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
14022 General & Plastic Surgery devices
8351–8375 of 14022
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
Cleared Jan 27, 2000
ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT
K992991 · Atrium Medical Corp.
FTL · Mesh, Surgical, Polymeric · 142d
Cleared Jan 24, 2000
CANDELA SCLERO LONG PULSE DYE LASER
K993671 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 84d
Cleared Jan 21, 2000
XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT
K992855 · Xomed, Inc.
QPB · System, Suction, Lipoplasty For Removal · 150d
Cleared Jan 20, 2000
EC-7701 FLUID WARMING CABINET
K993797 · Enthermics Medical Systems, Inc.
LDQ · 72d
Cleared Jan 20, 2000
MTP DISPOSABLE TROCARS
K994066 · Mtp Medical Technical Promotion GmbH
GCJ · Laparoscope, General & Plastic Surgery · 50d
Cleared Jan 20, 2000
STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTECH RADIOFREQUENCY GENERATOR, MODEL 1025A-230
K994173 · Stellartech Research Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 41d

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All categories 14022 GEX Powered Laser Surgical Instrument 2373 GEI Electrosurgical, Cutting & Coagulation & Accessories 1872 GCJ Laparoscope, General & Plastic Surgery 1114 FRO Dressing, Wound, Drug 574 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 257 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 160 EFQ Gauze/sponge, Internal 157 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 157 KMF Bandage, Liquid 155