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
13747 General & Plastic Surgery devices
Cleared
Dec 03, 2013
HEM-O-LOK LIGATING CLIP
FZP
Clip, Implantable
47d
Cleared
Dec 03, 2013
AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR
GEI
Electrosurgical, Cutting & Coagulation & Accessories
71d
Cleared
Dec 03, 2013
HARVESTING CANNULA
GEI
Electrosurgical, Cutting & Coagulation & Accessories
91d
Cleared
Dec 03, 2013
CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM
NEU
Marker, Radiographic, Implantable
118d
Cleared
Dec 03, 2013
SURGISEAL TOPICAL SKIN ADHESIVE
MPN
Tissue Adhesive For The Topical Approximation Of Skin
295d
Cleared
Dec 02, 2013
OPTIFIX ABSORBABLE FIXATION SYSTEM
GDW
Staple, Implantable
144d
Cleared
Nov 29, 2013
TRANQUILL BARBED DEVICE
NEW
Suture, Surgical, Absorbable, Polydioxanone
21d
Cleared
Nov 27, 2013
HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS
FZP
Clip, Implantable
93d
Cleared
Nov 27, 2013
GENESIS LED WANDS
GEX
Powered Laser Surgical Instrument
218d
Cleared
Nov 26, 2013
AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)
FTL
Mesh, Surgical, Polymeric
89d
Cleared
Nov 26, 2013
SHASER V-MINI RX
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
134d
Cleared
Nov 22, 2013
CLARITY LPC LASER SYSTEM
GEX
Powered Laser Surgical Instrument
298d
Cleared
Nov 19, 2013
V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS
OMP
Negative Pressure Wound Therapy Powered Suction Pump
26d
Cleared
Nov 15, 2013
V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM
OMP
Negative Pressure Wound Therapy Powered Suction Pump
73d
Cleared
Nov 15, 2013
MICROCYN SCAR MANAGEMENT HYDROGEL
PFP
Silicone Hydrogel For Scar Management
162d
Cleared
Nov 15, 2013
NEOVEIL
OXC
Mesh, Surgical, Absorbable, Staple Line Reinforcement
219d
Cleared
Nov 15, 2013
SYMPHONY RF GENERATOR
GEI
Electrosurgical, Cutting & Coagulation & Accessories
247d
Cleared
Nov 13, 2013
KULAVAC
OMP
Negative Pressure Wound Therapy Powered Suction Pump
455d
Cleared
Nov 07, 2013
DC 7
GEX
Powered Laser Surgical Instrument
139d
Cleared
Nov 05, 2013
VIDA LED SURGICAL LIGHTING SYSTEM
FSY
Light, Surgical, Ceiling Mounted
104d
Cleared
Oct 31, 2013
NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
GEX
Powered Laser Surgical Instrument
128d
Cleared
Oct 30, 2013
SMITH & NEPHEW ULTRATAPE
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
93d
Cleared
Oct 30, 2013
MESO BILAYER SURGICAL MESH
FTM
Mesh, Surgical
121d
Cleared
Oct 30, 2013
AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS
FSY
Light, Surgical, Ceiling Mounted
127d
Cleared
Oct 29, 2013
WOUNDWASH SALINE SPRAY
FRO
Dressing, Wound, Drug
314d
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