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
7691 General & Plastic Surgery devices
Cleared
Aug 23, 2002
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
FTL
Mesh, Surgical, Polymeric
35d
Cleared
Aug 23, 2002
BCLEAR
FTC
Light, Ultraviolet, Dermatological
86d
Cleared
Aug 21, 2002
DORNIER MEDILAS H LASER FIBER CABLES
GEX
Powered Laser Surgical Instrument
20d
Cleared
Aug 19, 2002
DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS
GEX
Powered Laser Surgical Instrument
87d
Cleared
Aug 02, 2002
BONESOURCE HAC
GXP
Methyl Methacrylate For Cranioplasty
88d
Cleared
Jul 16, 2002
BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301
FTL
Mesh, Surgical, Polymeric
49d
Cleared
Jul 11, 2002
AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V
GEI
Electrosurgical, Cutting & Coagulation & Accessories
38d
Cleared
Jul 11, 2002
COBRA CARDIAC ELECTROSURGICAL SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
232d
Cleared
Jul 09, 2002
WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
JCT
Prosthesis, Tracheal, Expandable
29d
Cleared
Jul 09, 2002
AURORA DS
GEX
Powered Laser Surgical Instrument
90d
Cleared
Jul 02, 2002
CANDELA VBEAM PULSED DYE LASER SYSTEM
GEX
Powered Laser Surgical Instrument
78d
Cleared
Jul 02, 2002
LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)
GEX
Powered Laser Surgical Instrument
180d
Cleared
Jul 01, 2002
ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX
GEI
Electrosurgical, Cutting & Coagulation & Accessories
89d
Cleared
Jun 26, 2002
CONMED HEATWAVE HAND-CONTROLLED ELETRODE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
63d
Cleared
Jun 26, 2002
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000
NAY
System, Surgical, Computer Controlled Instrument
86d
Cleared
Jun 21, 2002
CANDELA CBEAM PULSED DYE LASER SYSTEM
GEX
Powered Laser Surgical Instrument
88d
Cleared
Jun 21, 2002
ABSORBENT ANTIMICROBIAL WOUND DRESSING
FRO
Dressing, Wound, Drug
217d
Cleared
Jun 13, 2002
NUVASIVE MESH
EZX
Mesh, Surgical, Metal
90d
Cleared
Jun 06, 2002
ARTHROCARE CONTROLLER, AUTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
27d
Cleared
Jun 05, 2002
PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS
GDW
Staple, Implantable
86d
Cleared
May 30, 2002
MODIFICATION TO ENTEC PLASMA WANDS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
30d
Cleared
May 28, 2002
KSEA SCB MEDIA CONTROL
FTA
Light, Surgical, Accessories
90d
Cleared
May 13, 2002
AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03
GEI
Electrosurgical, Cutting & Coagulation & Accessories
81d
Cleared
May 06, 2002
WET CHAMBER
NAD
Dressing, Wound, Occlusive
56d
Cleared
May 02, 2002
SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWER CORD, AND VISAGE WANDSFF
GEI
Electrosurgical, Cutting & Coagulation & Accessories
84d
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