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
13836 General & Plastic Surgery devices
Cleared
May 13, 2010
SPINEWAND SURGICAL DEVICE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
90d
Cleared
May 12, 2010
REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
76d
Cleared
May 12, 2010
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
244d
Cleared
May 10, 2010
HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
126d
Cleared
May 05, 2010
PARIE TENE PROGRIP MESH
FTL
Mesh, Surgical, Polymeric
7d
Cleared
May 04, 2010
DERMABOND NX ADHESIVE MODEL: DNX6, DNX12
MPN
Tissue Adhesive For The Topical Approximation Of Skin
77d
Cleared
Apr 30, 2010
PRELOADED TISSUE MARKER DEVICE
NEU
Marker, Radiographic, Implantable
21d
Not Cleared
Apr 30, 2010
PRINEO SKIN CLOSURE SYSTEM
OMD
Cutaneous Tissue Adhesive With Mesh
402d
Cleared
Apr 23, 2010
ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP
FZP
Clip, Implantable
295d
Cleared
Apr 22, 2010
SPECIMEN RETRIEVAL SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
15d
Cleared
Apr 22, 2010
TORNIER SURGICAL MESH
FTL
Mesh, Surgical, Polymeric
133d
Cleared
Apr 21, 2010
VENTRIO HERNIA PATCH
FTL
Mesh, Surgical, Polymeric
85d
Cleared
Apr 15, 2010
CLARO
OLP
Over-the-counter Powered Light Based Laser For Acne
391d
Cleared
Apr 12, 2010
FIBERLASE C02 LASER WAVEGUIDE
GEX
Powered Laser Surgical Instrument
55d
Cleared
Apr 07, 2010
HARMONIC FOCUS SHEARS
LFL
Instrument, Ultrasonic Surgical
36d
Cleared
Apr 07, 2010
ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25
GDW
Staple, Implantable
113d
Cleared
Apr 02, 2010
ALEXIS ORTHOPAEDIC WOUND RETRACTOR
KGW
Ring (wound Protector), Drape Retention, Internal
77d
Cleared
Mar 29, 2010
ARTISAN AESTHETIC SYSTEM
GEX
Powered Laser Surgical Instrument
59d
Cleared
Mar 18, 2010
CP-FIBER (ORTHOFIBER)
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
78d
Cleared
Mar 17, 2010
HARMONY VLED SURGICAL LIGHTNING SYSTEM
FST
Light, Surgical, Fiberoptic
29d
Cleared
Mar 17, 2010
MODEL VISULAS 532S LASER WITH THE VITE OPTION
GEX
Powered Laser Surgical Instrument
70d
Cleared
Mar 12, 2010
EZLASE 3 LASER SYSTEM
GEX
Powered Laser Surgical Instrument
86d
Cleared
Mar 10, 2010
FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
16d
Cleared
Mar 04, 2010
REPROCESSED ULTRASONIC COAGULATING SHEARS
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
93d
Cleared
Mar 03, 2010
MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
KAM
Cannula, Sinus
104d
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