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
13580 General & Plastic Surgery devices
Cleared
Jul 24, 2020
Arthrex SutureTape
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
214d
Cleared
Jul 23, 2020
LG Pra. L Derma LD Scalp Care
OAP
Laser, Comb, Hair
148d
Cleared
Jul 22, 2020
Picowon
GEX
Powered Laser Surgical Instrument
55d
Cleared
Jul 22, 2020
InMode RF Multi-System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
84d
Cleared
Jul 20, 2020
BioSiCar Silicone Implant
MIB
Elastomer, Silicone Block
227d
Cleared
Jul 17, 2020
Signia Stapler (with new software)
GDW
Staple, Implantable
28d
Cleared
Jul 17, 2020
S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable
GCJ
Laparoscope, General & Plastic Surgery
74d
Cleared
Jul 17, 2020
3DMax MID Anatomical Mesh
FTL
Mesh, Surgical, Polymeric
109d
Cleared
Jul 17, 2020
Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head
OWN
Confocal Optical Imaging
136d
Cleared
Jul 16, 2020
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
GEX
Powered Laser Surgical Instrument
27d
Cleared
Jul 16, 2020
KeraStat Cream
KGN
Wound Dressing With Animal-derived Material(s)
317d
Cleared
Jul 15, 2020
CO2 Laser Therapy System
GEX
Powered Laser Surgical Instrument
79d
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
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