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
4081 General & Plastic Surgery devices
Cleared
Jul 15, 2020
V30 System, V20 System, V10 System, V-FR Handpiece
PBX
Massager, Vacuum, Radio Frequency Induced Heat
85d
Cleared
Jul 15, 2020
Encision AEM enTouch 2X Scissor
GEI
Electrosurgical, Cutting & Coagulation & Accessories
89d
Cleared
Jul 13, 2020
Allograft MIS Delivery System
FMF
Syringe, Piston
54d
Cleared
Jul 13, 2020
Biodesign Staple Line Reinforcement
FTM
Mesh, Surgical
88d
Cleared
Jul 10, 2020
Disposable Specimen Retrieval Bag
GCJ
Laparoscope, General & Plastic Surgery
63d
Cleared
Jul 10, 2020
Sonicision Cordless Ultrasonic Dissector
LFL
Instrument, Ultrasonic Surgical
140d
Cleared
Jul 09, 2020
HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)
NEY
System, Ablation, Microwave And Accessories
178d
Cleared
Jul 09, 2020
GTK Trocars
GCJ
Laparoscope, General & Plastic Surgery
226d
Cleared
Jul 08, 2020
Looking Glass 4K Integrated Visualization System
GCJ
Laparoscope, General & Plastic Surgery
26d
Cleared
Jul 08, 2020
ACTIV.A.C. Negative Pressure Wound Therapy System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
27d
Cleared
Jul 07, 2020
REXSIN
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
140d
Cleared
Jul 02, 2020
InMode System with the Morhpeus8 Applicators
GEI
Electrosurgical, Cutting & Coagulation & Accessories
85d
Cleared
Jul 02, 2020
Psoria-Shield AURORA
FTC
Light, Ultraviolet, Dermatological
302d
Cleared
Jun 30, 2020
Litho 150, Cyber Ho 150
GEX
Powered Laser Surgical Instrument
29d
Cleared
Jun 30, 2020
TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
FST
Light, Surgical, Fiberoptic
90d
Cleared
Jun 29, 2020
Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green
GDW
Staple, Implantable
130d
Cleared
Jun 26, 2020
Venus Viva MD Device
GEI
Electrosurgical, Cutting & Coagulation & Accessories
56d
Cleared
Jun 26, 2020
Stardust Med
GEX
Powered Laser Surgical Instrument
95d
Cleared
Jun 26, 2020
D-Stat Radial Topical Hemostat
QSX
Hemostatic Wound Dressing With Thrombin Or Other Biologics
99d
Cleared
Jun 24, 2020
Nd: YAG Laser Therapy Systems
GEX
Powered Laser Surgical Instrument
191d
Cleared
Jun 22, 2020
O-Mec 690 Series Laparoscopes
GCJ
Laparoscope, General & Plastic Surgery
54d
Cleared
Jun 22, 2020
Opera Lebody (Gold), Opera Lebody (Zafiro)
OHS
Light Based Over The Counter Wrinkle Reduction
59d
Cleared
Jun 19, 2020
Kogent Torus Ultrasonic Aspirator
LFL
Instrument, Ultrasonic Surgical
240d
Cleared
Jun 17, 2020
ArtiSential Laparoscopic Instruments - Electrodes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
77d
Cleared
Jun 17, 2020
LT Antibacterial Alginate with Silver Dressing
FRO
Dressing, Wound, Drug
281d
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