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
13717 General & Plastic Surgery devices
Cleared
May 15, 2015
SculpSure
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
102d
Cleared
May 14, 2015
PURICORE WOUND HYDROGEL SPRAY DRESSING
FRO
Dressing, Wound, Drug
308d
Cleared
May 12, 2015
Miromatrix Biological Mesh RS
OXH
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
90d
Cleared
May 12, 2015
Venus Viva SR Device
GEI
Electrosurgical, Cutting & Coagulation & Accessories
109d
Cleared
May 08, 2015
Aspen Laser Systems Therapy Laser System
PDZ
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
106d
Cleared
May 08, 2015
AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
155d
Cleared
May 08, 2015
DERMAFINE
FRO
Dressing, Wound, Drug
394d
Cleared
May 07, 2015
Insightra Freedom Ventral Hernia Repair System
FTL
Mesh, Surgical, Polymeric
269d
Cleared
May 05, 2015
ILUMIEN, Drageonfly OPTIS Imaging Catheter
NQQ
System, Imaging, Optical Coherence Tomography (oct)
92d
Cleared
May 04, 2015
ERBECRYO 2 Cryosurgical Unit with accessories
GEH
Unit, Cryosurgical, Accessories
14d
Cleared
May 01, 2015
BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
FCG
Biopsy Needle
29d
Cleared
May 01, 2015
V10 system
PBX
Massager, Vacuum, Radio Frequency Induced Heat
112d
Cleared
Apr 30, 2015
SILVERLON BURN CONTACT DRESSINGS
FRO
Dressing, Wound, Drug
86d
Cleared
Apr 30, 2015
XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and
OMP
Negative Pressure Wound Therapy Powered Suction Pump
225d
Cleared
Apr 29, 2015
IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps
NAY
System, Surgical, Computer Controlled Instrument
30d
Cleared
Apr 29, 2015
ULTRA Telescopes
GCJ
Laparoscope, General & Plastic Surgery
49d
Cleared
Apr 29, 2015
RENASYS
OMP
Negative Pressure Wound Therapy Powered Suction Pump
196d
Cleared
Apr 29, 2015
ST'RIM
MUU
System, Suction, Lipoplasty
272d
Cleared
Apr 28, 2015
CAS-One Liver
OEW
Tracking, Soft Tissue, Intraoperative
189d
Cleared
Apr 24, 2015
Artoura Breast Tissue Expander
LCJ
Tissue Expander And Accessories
30d
Cleared
Apr 24, 2015
Lipofina Laser System
OLI
Fat Reducing Low Level Laser
114d
Cleared
Apr 24, 2015
SILHOUETTE INSTALIFT
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
268d
Cleared
Apr 23, 2015
NICO TRIOwand
GEI
Electrosurgical, Cutting & Coagulation & Accessories
8d
Cleared
Apr 23, 2015
Noblex Long Pulse Alexandrite Laser
GEX
Powered Laser Surgical Instrument
121d
Cleared
Apr 21, 2015
Basic, Dominant Flex, KV-6
QPB
System, Suction, Lipoplasty For Removal
90d
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