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
18256
Total
18211
Cleared
136d
Avg (2y)
1976
Since
7628 General & Plastic Surgery devices
Cleared
May 18, 2018
Theradome LH40
OAP
Laser, Comb, Hair
87d
Cleared
May 18, 2018
XSTAT 30, 1-Pack
PGZ
Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
130d
Cleared
May 15, 2018
ICEfx Cryoablation System
GEH
Unit, Cryosurgical, Accessories
14d
Cleared
May 15, 2018
reVive Light Therapy LED Ultrasonic Wrinkle System
OHS
Light Based Over The Counter Wrinkle Reduction
84d
Cleared
May 11, 2018
Cytal Wound Particulate
KGN
Wound Dressing With Animal-derived Material(s)
49d
Cleared
May 11, 2018
Light based hair removal device
OHT
Light Based Over-the-counter Hair Removal
88d
Cleared
May 11, 2018
ALGS6 Ag Alginate Wound Dressing
FRO
Dressing, Wound, Drug
256d
Cleared
May 10, 2018
Rondek PGA Suture (Beige or Violet)
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
62d
Cleared
May 09, 2018
Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad
OMP
Negative Pressure Wound Therapy Powered Suction Pump
296d
Cleared
May 08, 2018
Empower H100, Cyber Ho 100, Litho 100
GEX
Powered Laser Surgical Instrument
29d
Cleared
May 07, 2018
Endopath Electrosurgery Probe Plus II
GEI
Electrosurgical, Cutting & Coagulation & Accessories
123d
Not Cleared
May 07, 2018
Hemospray Endoscopic Hemostat
QAU
Hemostatic Device For Endoscopic Gastrointestinal Use
424d
Cleared
May 04, 2018
Ulthera System
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
56d
Cleared
May 04, 2018
StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
134d
Cleared
May 03, 2018
VivaScope System
PSN
Light Based Imaging
104d
Cleared
May 01, 2018
AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches
GEI
Electrosurgical, Cutting & Coagulation & Accessories
29d
Cleared
May 01, 2018
SAPPHIRE, ELEVARE SAPPHIRE
OLP
Over-the-counter Powered Light Based Laser For Acne
250d
Cleared
May 01, 2018
LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing
FRO
Dressing, Wound, Drug
250d
Cleared
Apr 30, 2018
VitaMESH Macroporous PP Surgical Mesh
FTL
Mesh, Surgical, Polymeric
241d
Cleared
Apr 27, 2018
HYALURONIC ACID TOPICAL WOUND CREAM
FRO
Dressing, Wound, Drug
227d
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
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