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
13841 General & Plastic Surgery devices
Cleared
Dec 22, 2008
EZLASE
GEX
Powered Laser Surgical Instrument
81d
Cleared
Dec 19, 2008
SURGISEAL TOPICAL SKIN ADHESIVE
MPN
Tissue Adhesive For The Topical Approximation Of Skin
73d
Cleared
Dec 19, 2008
SMOOTHCOOL HR SYSTEM
GEX
Powered Laser Surgical Instrument
80d
Cleared
Dec 19, 2008
3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
99d
Cleared
Dec 19, 2008
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE
NAY
System, Surgical, Computer Controlled Instrument
234d
Cleared
Dec 18, 2008
INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS
GDW
Staple, Implantable
20d
Cleared
Dec 18, 2008
WOUND FLUSH, STERILE WATER & NORMAL SALINE
FRO
Dressing, Wound, Drug
65d
Cleared
Dec 18, 2008
ALPHA ORTHOPAEDICS AT2 SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
76d
Cleared
Dec 18, 2008
ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM
GEX
Powered Laser Surgical Instrument
85d
Cleared
Dec 18, 2008
GENADYNE A4 WOUND VACUUM SYSTEM
OMP
Negative Pressure Wound Therapy Powered Suction Pump
94d
Cleared
Dec 18, 2008
VIKY
GCJ
Laparoscope, General & Plastic Surgery
133d
Cleared
Dec 17, 2008
ML24000 UVA-1 PHOTOTHERAPY CABINET
FTC
Light, Ultraviolet, Dermatological
90d
Cleared
Dec 17, 2008
GRAFTGUARD PRESSURE CONTROLLING SYRINGE
GBX
Catheter, Irrigation
91d
Cleared
Dec 16, 2008
SKINCLEAR Q-SWITCHED ND:YAG LASER
GEX
Powered Laser Surgical Instrument
40d
Cleared
Dec 16, 2008
MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS
NEU
Marker, Radiographic, Implantable
127d
Cleared
Dec 16, 2008
MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
274d
Cleared
Dec 15, 2008
AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
45d
Cleared
Dec 12, 2008
PRIMATRIX DERMAL REPAIR SCAFFOLD
KGN
Wound Dressing With Animal-derived Material(s)
22d
Cleared
Dec 12, 2008
CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE
GEX
Powered Laser Surgical Instrument
28d
Cleared
Dec 12, 2008
PROLITE III TOWER AND PR AND HR HANDPIECE
GEX
Powered Laser Surgical Instrument
239d
Cleared
Dec 10, 2008
MODIFICATION TO ARTHROCARE ARTHROWANDS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
30d
Cleared
Dec 10, 2008
RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
71d
Cleared
Dec 09, 2008
PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001
GEI
Electrosurgical, Cutting & Coagulation & Accessories
61d
Cleared
Dec 04, 2008
TIVAMED COOLED RF SYSTEM, MODEL 78001
GEI
Electrosurgical, Cutting & Coagulation & Accessories
62d
Cleared
Dec 04, 2008
LIPOSE FAT TRANSFER SYSTEM
MUU
System, Suction, Lipoplasty
157d
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