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
13656 General & Plastic Surgery devices
Cleared
May 01, 2017
Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
213d
Cleared
Apr 28, 2017
Biodesign Staple Line Reinforcement
OXE
Mesh, Surgical, Collagen, Staple Line Reinforcement
29d
Cleared
Apr 28, 2017
RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack)
PBY
Temporary Tissue Marker
122d
Cleared
Apr 28, 2017
VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing
OMP
Negative Pressure Wound Therapy Powered Suction Pump
269d
Cleared
Apr 27, 2017
Star Tissue Marker
NEU
Marker, Radiographic, Implantable
30d
Cleared
Apr 27, 2017
U.S. Laser Worx Patriot 1 family of lasers
GEX
Powered Laser Surgical Instrument
248d
Cleared
Apr 26, 2017
Restrata Wound Matrix
QSZ
Absorbable Synthetic Wound Dressing
85d
Cleared
Apr 25, 2017
Cutera enlighten III Laser System
GEX
Powered Laser Surgical Instrument
26d
Cleared
Apr 25, 2017
BC-001+ Acne Purifier
OLP
Over-the-counter Powered Light Based Laser For Acne
88d
Cleared
Apr 25, 2017
Triton Sponge System
PBZ
Image Processing Device For Estimation Of External Blood Loss
132d
Cleared
Apr 21, 2017
LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated
GEI
Electrosurgical, Cutting & Coagulation & Accessories
29d
Cleared
Apr 21, 2017
EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories
NAY
System, Surgical, Computer Controlled Instrument
29d
Cleared
Apr 21, 2017
Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil
GEI
Electrosurgical, Cutting & Coagulation & Accessories
43d
Cleared
Apr 21, 2017
joimax Endovapor 2
GEI
Electrosurgical, Cutting & Coagulation & Accessories
74d
Cleared
Apr 21, 2017
DERMABOND PRINEO Skin Closure System
OMD
Cutaneous Tissue Adhesive With Mesh
119d
Cleared
Apr 20, 2017
SlimShape System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
136d
Cleared
Apr 20, 2017
Ross Ru Wound Dressing Gel
FRO
Dressing, Wound, Drug
273d
Cleared
Apr 19, 2017
LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock
GEX
Powered Laser Surgical Instrument
85d
Cleared
Apr 18, 2017
Model 330 Multifunction Aspirator
BTA
Pump, Portable, Aspiration (manual Or Powered)
54d
Cleared
Apr 18, 2017
ECHELON CIRCULAR Powered Stapler
GDW
Staple, Implantable
124d
Cleared
Apr 18, 2017
PICO Single Use Negative Pressure Wound Therapy System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
137d
Cleared
Apr 17, 2017
Paxman Scalp Cooler
PMC
Scalp Cooling System
126d
Cleared
Apr 14, 2017
Saf-T-Vac Smoke and Fluid Evacuator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
45d
Cleared
Apr 14, 2017
Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72
OHS
Light Based Over The Counter Wrinkle Reduction
137d
Cleared
Apr 13, 2017
PlasmaBlade T
GEI
Electrosurgical, Cutting & Coagulation & Accessories
43d
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