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
13712 General & Plastic Surgery devices
Cleared
Jul 23, 2015
PROTOCOL Incision Dressing
FRO
Dressing, Wound, Drug
282d
Cleared
Jul 22, 2015
LaserCap LC Pro and LC Elite
OAP
Laser, Comb, Hair
134d
Cleared
Jul 22, 2015
Nutra Light Advanced
OLP
Over-the-counter Powered Light Based Laser For Acne
159d
Cleared
Jul 21, 2015
Caiman Seal and Cut Technology
GEI
Electrosurgical, Cutting & Coagulation & Accessories
13d
Cleared
Jul 21, 2015
Cortex Laser System
GEX
Powered Laser Surgical Instrument
134d
Cleared
Jul 21, 2015
NovoStitch Plus Meniscal Repair System
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
239d
Cleared
Jul 20, 2015
Caiman Seal and Cut Technology
GEI
Electrosurgical, Cutting & Coagulation & Accessories
27d
Cleared
Jul 17, 2015
ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks
GDW
Staple, Implantable
28d
Cleared
Jul 17, 2015
Lotus Series 4 Ultrasonic Surgical System & Accessories
LFL
Instrument, Ultrasonic Surgical
84d
Cleared
Jul 17, 2015
SURGISEAL Topical Skin Adhesvie
MPN
Tissue Adhesive For The Topical Approximation Of Skin
107d
Cleared
Jul 16, 2015
RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device
OMP
Negative Pressure Wound Therapy Powered Suction Pump
59d
Cleared
Jul 16, 2015
PROPENCIL Smoke Pencil
GEI
Electrosurgical, Cutting & Coagulation & Accessories
260d
Cleared
Jul 15, 2015
ILUMIEN OPTIS
NQQ
System, Imaging, Optical Coherence Tomography (oct)
105d
Cleared
Jul 10, 2015
HARMONIC Focus Long Shears + Adaptive Tissue Technology
LFL
Instrument, Ultrasonic Surgical
52d
Cleared
Jul 10, 2015
Houva-NET Control System
FTC
Light, Ultraviolet, Dermatological
98d
Cleared
Jul 07, 2015
Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System
GEH
Unit, Cryosurgical, Accessories
78d
Cleared
Jul 07, 2015
Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
GEX
Powered Laser Surgical Instrument
95d
Cleared
Jul 02, 2015
VersaOne Bladed Trocar, VersaOne Bladeless Trocar
GCJ
Laparoscope, General & Plastic Surgery
23d
Cleared
Jul 02, 2015
LTM-Perforated Surgical Mesh
FTM
Mesh, Surgical
105d
Cleared
Jul 02, 2015
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
NEW
Suture, Surgical, Absorbable, Polydioxanone
108d
Cleared
Jul 01, 2015
SculpSure
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
103d
Cleared
Jul 01, 2015
SILKPRO laser hair removal system
OHT
Light Based Over-the-counter Hair Removal
274d
Cleared
Jun 30, 2015
The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch
GEX
Powered Laser Surgical Instrument
42d
Cleared
Jun 30, 2015
Artemis Hand Held Imaging System
OWN
Confocal Optical Imaging
207d
Cleared
Jun 29, 2015
Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
139d
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