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
13639 General & Plastic Surgery devices
Cleared
Apr 26, 2018
ESG-300, APU-300, Pressure Reducer, MAPC Probes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
92d
Cleared
Apr 26, 2018
Intuitive Surgical EndoWrist Vessel Sealer Extend
NAY
System, Surgical, Computer Controlled Instrument
185d
Cleared
Apr 25, 2018
Phasix ST Mesh
OWT
Mesh, Surgical, Absorbable, Abdominal Hernia
208d
Cleared
Apr 25, 2018
Oniko nail brace
MQZ
Prosthesis, Nail
593d
Cleared
Apr 24, 2018
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
FTL
Mesh, Surgical, Polymeric
111d
Cleared
Apr 23, 2018
Reprocessed LigaSure Maryland Jaw Sealer/Divider
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
56d
Cleared
Apr 23, 2018
da Vinci Xi Surgical System, da Vinci X Surgical System
NAY
System, Surgical, Computer Controlled Instrument
126d
Cleared
Apr 20, 2018
PICO Single Use Negative Pressure Wound Therapy System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
42d
Cleared
Apr 20, 2018
Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
59d
Cleared
Apr 20, 2018
ProFlex Laser Fibers
GEX
Powered Laser Surgical Instrument
92d
Cleared
Apr 20, 2018
Etherea MX
GEX
Powered Laser Surgical Instrument
339d
Cleared
Apr 19, 2018
Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)
LEJ
Booth, Sun Tan
45d
Cleared
Apr 18, 2018
Genistrong
GCJ
Laparoscope, General & Plastic Surgery
19d
Cleared
Apr 17, 2018
Diode laser hair removal device
GEX
Powered Laser Surgical Instrument
68d
Cleared
Apr 17, 2018
THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S
GEI
Electrosurgical, Cutting & Coagulation & Accessories
229d
Cleared
Apr 13, 2018
Voyant Open Fusion Device
GEI
Electrosurgical, Cutting & Coagulation & Accessories
28d
Cleared
Apr 13, 2018
Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)
FRO
Dressing, Wound, Drug
70d
Cleared
Apr 12, 2018
StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
269d
Cleared
Apr 09, 2018
Aurora Evacuator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
56d
Cleared
Apr 09, 2018
Disposable Endoscopic Trocar
GCJ
Laparoscope, General & Plastic Surgery
75d
Cleared
Apr 09, 2018
Medline Cautery Electrode (PTFE)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
109d
Cleared
Apr 06, 2018
PTFE SURGICAL SUTURE
NBY
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
28d
Cleared
Apr 06, 2018
PICO Single Use Negative Pressure Wound Therapy System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
29d
Cleared
Apr 06, 2018
Viveve RF System, Secure
GEI
Electrosurgical, Cutting & Coagulation & Accessories
32d
Cleared
Apr 06, 2018
8mm Monopolar Curved Scissors
NAY
System, Surgical, Computer Controlled Instrument
92d
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