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
18201
Total
18157
Cleared
138d
Avg (2y)
1976
Since
4091 General & Plastic Surgery devices
Cleared
May 23, 2019
Longterm NPWT Foam Dressing Kit
OMP
Negative Pressure Wound Therapy Powered Suction Pump
255d
Cleared
May 22, 2019
Erbe ESU Model VIO 3 with Accessories
GEI
Electrosurgical, Cutting & Coagulation & Accessories
51d
Cleared
May 22, 2019
Soniquence RF Generator and Soniquence Electrodes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
147d
Cleared
May 21, 2019
Smith & Nephew Tablet Application
QGY
Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
95d
Cleared
May 17, 2019
iRestore Professional 282
OAP
Laser, Comb, Hair
158d
Cleared
May 15, 2019
REMY Medical Therapy Laser System
PDZ
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
128d
Cleared
May 10, 2019
L10 LED Light Source with AIM, L11 LED Light Source with AIM
OWN
Confocal Optical Imaging
21d
Cleared
May 10, 2019
Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound
LEJ
Booth, Sun Tan
98d
Cleared
May 10, 2019
SteriStay
ORC
Air Filter Portable Apparatus
123d
Cleared
May 08, 2019
Electrosurgical accessory
GEI
Electrosurgical, Cutting & Coagulation & Accessories
176d
Cleared
May 06, 2019
Medline Electrocautery Pencil
GEI
Electrosurgical, Cutting & Coagulation & Accessories
54d
Cleared
May 03, 2019
AuraGen 123 Suction Lipoplasty System (A123)
MUU
System, Suction, Lipoplasty
84d
Cleared
May 02, 2019
SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
MUD
Oximeter, Tissue Saturation
58d
Cleared
May 02, 2019
TRIO Handpiece
GEX
Powered Laser Surgical Instrument
164d
Cleared
May 01, 2019
HS Fiber
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
30d
Cleared
May 01, 2019
PowerX Lipo System
QPB
System, Suction, Lipoplasty For Removal
57d
Cleared
May 01, 2019
VASERlipo System
QPB
System, Suction, Lipoplasty For Removal
57d
Cleared
Apr 29, 2019
YelloPort Elite Port Access System
GCJ
Laparoscope, General & Plastic Surgery
53d
Cleared
Apr 25, 2019
Ranfac Cartilage Biopsy Needle
KNW
Instrument, Biopsy
163d
Cleared
Apr 24, 2019
IntelliCartTM System
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
28d
Cleared
Apr 24, 2019
V-Laser
GEX
Powered Laser Surgical Instrument
160d
Cleared
Apr 22, 2019
CryoLab
GEH
Unit, Cryosurgical, Accessories
60d
Cleared
Apr 19, 2019
SPY Portable Handheld Imaging (SPY-PHI) System
OWN
Confocal Optical Imaging
29d
Not Cleared
Apr 19, 2019
PREVENA 125 and PREVENA PLUS 125 Therapy Units
QFC
Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
400d
Cleared
Apr 18, 2019
Disposable Standard Clamp
GCJ
Laparoscope, General & Plastic Surgery
22d
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