FDA 510(k) General & Plastic Surgery Devices
About General & Plastic Surgery Devices
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
18146
Total
18103
Cleared
114d
Avg days
1976
Since
1328 General & Plastic Surgery devices
Cleared
Jun 09, 2023
NovoGen Wound Matrix
KGN
Wound Dressing With Animal-derived Material(s)
472d
Cleared
Jun 06, 2023
AviClear Laser System
GEX
Powered Laser Surgical Instrument
88d
Cleared
Jun 05, 2023
ArtiSential Laparoscopic Instruments-Electrodes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
101d
Cleared
Jun 01, 2023
Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)
GEX
Powered Laser Surgical Instrument
56d
Cleared
May 31, 2023
Pitch PaSoft Tissue Reinforcement Device
FTL
Mesh, Surgical, Polymeric
82d
Cleared
May 31, 2023
BTL-785X
GEI
Electrosurgical, Cutting & Coagulation & Accessories
281d
Cleared
May 25, 2023
ThermoTK
PBX
Massager, Vacuum, Radio Frequency Induced Heat
602d
Cleared
May 22, 2023
HELIOS 785 Pico
GEX
Powered Laser Surgical Instrument
98d
Cleared
May 18, 2023
Restrata® MiniMatrix
QSZ
Absorbable Synthetic Wound Dressing
156d
Cleared
May 16, 2023
Infrared Heat (Model: E0221)
OHS
Light Based Over The Counter Wrinkle Reduction
139d
Cleared
May 16, 2023
VERSAJET Hydrosurgery System (III)
FQH
Lavage, Jet
410d
Cleared
May 12, 2023
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
NAY
System, Surgical, Computer Controlled Instrument
14d
Cleared
May 08, 2023
Anika Tissue Tack Fixation System
GDW
Staple, Implantable
264d
Cleared
May 04, 2023
Pollogen STOP U Model UXV Device
PAY
Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction
455d
Cleared
May 02, 2023
NuEra Tight RF Model APMD145.M70-US
PBX
Massager, Vacuum, Radio Frequency Induced Heat
125d
Cleared
May 02, 2023
FortiShield (Biosynthetic Wound Matrix)
KGN
Wound Dressing With Animal-derived Material(s)
624d
Cleared
Apr 28, 2023
Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
OAP
Laser, Comb, Hair
56d
Cleared
Apr 28, 2023
Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)
FZP
Clip, Implantable
65d
Cleared
Apr 28, 2023
Bladeless Trocar – Artemis Lap Cannula
GCJ
Laparoscope, General & Plastic Surgery
109d
Cleared
Apr 28, 2023
Q-Rejuvalight Pro Facewear (Model: P19-0023)
OHS
Light Based Over The Counter Wrinkle Reduction
112d
Cleared
Apr 28, 2023
Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
OAP
Laser, Comb, Hair
126d
Cleared
Apr 27, 2023
Braun Skin i.expert
OHT
Light Based Over-the-counter Hair Removal
27d
Cleared
Apr 27, 2023
ArtiSential Laparoscopic Instruments-Electrodes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
59d
Cleared
Apr 26, 2023
ArtiSential Laparoscopic Instruments-Electrodes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
61d
Cleared
Apr 21, 2023
AEON Endoscopic Stapler
GDW
Staple, Implantable
270d
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