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
13726 General & Plastic Surgery devices
Cleared
Apr 21, 2015
Tranberg CLS Thermal Therapy System
GEX
Powered Laser Surgical Instrument
252d
Cleared
Apr 20, 2015
DeScribe Transparent PFD Patch
PKO
Transparent Patch For Use In Treatment Of Tattoos
80d
Cleared
Apr 20, 2015
IPM Wound Gel Bio, IPM Derm Gel Bio
FRO
Dressing, Wound, Drug
129d
Cleared
Apr 20, 2015
Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home
OMP
Negative Pressure Wound Therapy Powered Suction Pump
182d
Cleared
Apr 17, 2015
DIODE LASER HAIR REMOVAL SYSTEM
GEX
Powered Laser Surgical Instrument
252d
Cleared
Apr 16, 2015
PicoWay Laser System
GEX
Powered Laser Surgical Instrument
66d
Cleared
Apr 16, 2015
Voyant Fine Fusion Device
GEI
Electrosurgical, Cutting & Coagulation & Accessories
122d
Cleared
Apr 16, 2015
BIOPOR AOC POROUS POLYETHYLENE, CEREPOR
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
279d
Cleared
Apr 14, 2015
LX-100 Hair Growth Stimulation System
OAP
Laser, Comb, Hair
196d
Cleared
Apr 13, 2015
FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator
GCJ
Laparoscope, General & Plastic Surgery
26d
Cleared
Apr 13, 2015
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS
GEX
Powered Laser Surgical Instrument
42d
Cleared
Apr 13, 2015
Monopolar Laparascopic Accessories
GEI
Electrosurgical, Cutting & Coagulation & Accessories
245d
Cleared
Apr 10, 2015
BREAST-MED TISSUE MARKER
NEU
Marker, Radiographic, Implantable
493d
Cleared
Apr 09, 2015
LightStim Professional 2-Panel Light
OHS
Light Based Over The Counter Wrinkle Reduction
79d
Cleared
Apr 09, 2015
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
GEX
Powered Laser Surgical Instrument
101d
Cleared
Apr 09, 2015
KOGENT SPETZLER LIGHTED SUCTION TUBES
HBI
Illuminator, Fiberoptic, Surgical Field
281d
Cleared
Apr 08, 2015
Exilite
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
86d
Cleared
Apr 06, 2015
LUOFUCON SILVER FOAM DRESSING
FRO
Dressing, Wound, Drug
293d
Cleared
Apr 03, 2015
CYMA
GEX
Powered Laser Surgical Instrument
86d
Cleared
Apr 03, 2015
Valleylab LS10 Generator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
101d
Cleared
Apr 03, 2015
VAPR Tripolar Suction Electrode
GEI
Electrosurgical, Cutting & Coagulation & Accessories
119d
Cleared
Apr 02, 2015
Force Fiber OrthoTape suture
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
42d
Cleared
Apr 02, 2015
IS4000 8mm Harmonic ACE Curved Shears
NAY
System, Surgical, Computer Controlled Instrument
153d
Cleared
Apr 02, 2015
Tanning Lamp
LEJ
Booth, Sun Tan
162d
Cleared
Apr 01, 2015
Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm
GCJ
Laparoscope, General & Plastic Surgery
57d
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