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
13861 General & Plastic Surgery devices
Cleared
Jul 23, 2008
MEDELA THOPAZ, MODEL 200 0288
BTA
Pump, Portable, Aspiration (manual Or Powered)
176d
Cleared
Jul 23, 2008
FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
210d
Cleared
Jul 23, 2008
ZENIEVA
NAE
Dressing, Wound, Hydrogel Without Drug And/or Biologic
247d
Cleared
Jul 22, 2008
PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040
GEI
Electrosurgical, Cutting & Coagulation & Accessories
266d
Cleared
Jul 18, 2008
CHROMOLITE EP
GEX
Powered Laser Surgical Instrument
39d
Cleared
Jul 17, 2008
PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE
GEX
Powered Laser Surgical Instrument
125d
Cleared
Jul 15, 2008
KUMAR T-ANCHORS HERNIA SET
GAR
Suture, Nonabsorbable, Synthetic, Polyamide
61d
Cleared
Jul 15, 2008
TEPHAFLEX ABSORBABLE SUTURE
NWJ
Suture, Recombinant Technology
89d
Cleared
Jul 15, 2008
FENCER 308 EXCIMER LASER SYSTEM
GEX
Powered Laser Surgical Instrument
99d
Cleared
Jul 15, 2008
VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM
OMP
Negative Pressure Wound Therapy Powered Suction Pump
106d
Cleared
Jul 11, 2008
MODIFICATION TO XYLOS SURGICAL MESH
FTM
Mesh, Surgical
9d
Cleared
Jul 10, 2008
LIPO CANNULA
QPB
System, Suction, Lipoplasty For Removal
90d
Cleared
Jul 10, 2008
KEY LASER III 1243 US WITH DETECT
GEX
Powered Laser Surgical Instrument
253d
Cleared
Jul 09, 2008
MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
177d
Cleared
Jul 09, 2008
SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM
NTB
System, Ablation, Ultrasound And Accessories
476d
Cleared
Jul 08, 2008
CERALAS D 980NM DIODE LASER, MODELS D15 AND D25
GEX
Powered Laser Surgical Instrument
90d
Cleared
Jul 07, 2008
MOSAIC ECO2 LASER SYSTEM
GEX
Powered Laser Surgical Instrument
136d
Cleared
Jul 03, 2008
ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP
GDW
Staple, Implantable
90d
Cleared
Jul 03, 2008
UNIBLATE ELECTROSURGICAL DEVICE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
135d
Cleared
Jul 03, 2008
ONCOBIONIC BIPOLAR ELECTRODE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
150d
Cleared
Jul 01, 2008
FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES
GEX
Powered Laser Surgical Instrument
90d
Cleared
Jun 30, 2008
APOLLO MINI IPL SYSTEM
GEX
Powered Laser Surgical Instrument
61d
Cleared
Jun 27, 2008
DORNIER MEDILAS D 30 LASER, MEDILAS D 1064
GEX
Powered Laser Surgical Instrument
85d
Cleared
Jun 27, 2008
DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG)
FRO
Dressing, Wound, Drug
126d
Cleared
Jun 27, 2008
ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060
GEX
Powered Laser Surgical Instrument
326d
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