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
1320 General & Plastic Surgery devices
Cleared
Jun 14, 2024
3DMax Light Mesh
FTL
Mesh, Surgical, Polymeric
42d
Cleared
Jun 14, 2024
CanGaroo RM Antibacterial Envelope
FTM
Mesh, Surgical
179d
Cleared
Jun 13, 2024
BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E
GEX
Powered Laser Surgical Instrument
30d
Cleared
Jun 13, 2024
InMode System with the Morpheus8 90 Applicator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
163d
Cleared
Jun 13, 2024
3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)
GCJ
Laparoscope, General & Plastic Surgery
188d
Cleared
Jun 12, 2024
Picosecond Nd:YAG Laser System
GEX
Powered Laser Surgical Instrument
264d
Cleared
Jun 10, 2024
Medical Diode Laser (S1Pro)
GEX
Powered Laser Surgical Instrument
95d
Cleared
Jun 10, 2024
Histofreezer V
GEH
Unit, Cryosurgical, Accessories
146d
Cleared
Jun 06, 2024
ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
90d
Cleared
Jun 04, 2024
Dermalux Tri-Wave MD MKII (1000021)
GEX
Powered Laser Surgical Instrument
130d
Cleared
Jun 04, 2024
da Vinci SP Surgical System (SP1098)
NAY
System, Surgical, Computer Controlled Instrument
267d
Cleared
Jun 03, 2024
Maestro System (REF100)
FQO
Table, Operating-room, Ac-powered
91d
Cleared
May 31, 2024
Electro Lube NXT
GEI
Electrosurgical, Cutting & Coagulation & Accessories
44d
Cleared
May 31, 2024
IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)
OHT
Light Based Over-the-counter Hair Removal
52d
Cleared
May 31, 2024
Anti-bacterial bandage
FRO
Dressing, Wound, Drug
301d
Cleared
May 31, 2024
Puracyn® Plus Antimicrobial Irrigation Solution
FRO
Dressing, Wound, Drug
323d
Cleared
May 30, 2024
SofWave System
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
79d
Cleared
May 30, 2024
Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter
GEI
Electrosurgical, Cutting & Coagulation & Accessories
286d
Cleared
May 29, 2024
Temperature Sensor Probe (ABL-18TP20)
NEY
System, Ablation, Microwave And Accessories
69d
Cleared
May 29, 2024
InnoVoyce VYLO
GEX
Powered Laser Surgical Instrument
131d
Cleared
May 28, 2024
Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)
GEX
Powered Laser Surgical Instrument
60d
Cleared
May 28, 2024
Regenalase Laser System
GEX
Powered Laser Surgical Instrument
242d
Cleared
May 28, 2024
Laser Speckle Imaging System (RFLSI CZW)
DPT
Probe, Blood-flow, Extravascular
245d
Cleared
May 24, 2024
da Vinci Xi Surgical System (IS4000)
NAY
System, Surgical, Computer Controlled Instrument
67d
Cleared
May 24, 2024
Monik™ - Disposable Endoscopic Trocar
GCJ
Laparoscope, General & Plastic Surgery
235d
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