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
13559 General & Plastic Surgery devices
Cleared
Jan 05, 2021
ABI Instrument, Creo Electrosurgical System
NEY
System, Ablation, Microwave And Accessories
334d
Cleared
Jan 04, 2021
J-Plasma Precise FLEX Handpiece
GEI
Electrosurgical, Cutting & Coagulation & Accessories
98d
Cleared
Dec 24, 2020
UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories
GEX
Powered Laser Surgical Instrument
20d
Cleared
Dec 23, 2020
Plasdent Disposable Barrier Sleeves and Barrier Film
PEM
Dental Barriers And Sleeves
191d
Cleared
Dec 23, 2020
Customized Contour Implant
FWP
Prosthesis, Chin, Internal
289d
Cleared
Dec 22, 2020
Da Vinci SP Surgical System
NAY
System, Surgical, Computer Controlled Instrument
83d
Cleared
Dec 22, 2020
SoloAsisst II, Voice Control
NAY
System, Surgical, Computer Controlled Instrument
300d
Cleared
Dec 21, 2020
Monocryl Plus Antibacterial Suture
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
154d
Cleared
Dec 18, 2020
Aesculap Caiman 12 Seal and Cut Technology System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
24d
Cleared
Dec 18, 2020
UltraSlim Digital, UltraSmooth Digital
OLI
Fat Reducing Low Level Laser
121d
Cleared
Dec 18, 2020
ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
150d
Cleared
Dec 17, 2020
Emprint SX Ablation Platform with Thermosphere Technology
NEY
System, Ablation, Microwave And Accessories
38d
Cleared
Dec 17, 2020
KARL STORZ ICG Imaging System
OWN
Confocal Optical Imaging
79d
Cleared
Dec 17, 2020
Primelase Excellence
GEX
Powered Laser Surgical Instrument
188d
Cleared
Dec 17, 2020
Exofin High Viscosity Topical Skin Adhesive
MPN
Tissue Adhesive For The Topical Approximation Of Skin
318d
Cleared
Dec 16, 2020
HydroMARK Breast Biopsy Site Markers
NEU
Marker, Radiographic, Implantable
63d
Cleared
Dec 16, 2020
dermalux Flex MD
ILY
Lamp, Infrared, Therapeutic Heating
147d
Cleared
Dec 15, 2020
308nm Excimer UV-light Skin Therapy System
FTC
Light, Ultraviolet, Dermatological
82d
Cleared
Dec 15, 2020
Single-use Sterile medical laser fiber
GEX
Powered Laser Surgical Instrument
98d
Cleared
Dec 15, 2020
308nm Excimer System
FTC
Light, Ultraviolet, Dermatological
246d
Cleared
Dec 14, 2020
Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
GDW
Staple, Implantable
109d
Cleared
Dec 14, 2020
Irrisept Wound Debridement and Cleansing System
FQH
Lavage, Jet
130d
Cleared
Dec 14, 2020
PlaDuo System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
172d
Cleared
Dec 10, 2020
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
NAY
System, Surgical, Computer Controlled Instrument
76d
Cleared
Dec 09, 2020
V30 system, V20 system, V10 system, V-VR Hand piece
PBX
Massager, Vacuum, Radio Frequency Induced Heat
121d
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