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
13803 General & Plastic Surgery devices
Cleared
Dec 28, 2011
ENDOWRIST ONE VESSEL SEALER
NAY
System, Surgical, Computer Controlled Instrument
299d
Cleared
Dec 23, 2011
BIOMERIX ASSURE
FTL
Mesh, Surgical, Polymeric
112d
Cleared
Dec 23, 2011
BIOMERIX COMPOSITE SURGICAL MESH
FTL
Mesh, Surgical, Polymeric
115d
Cleared
Dec 22, 2011
VARI-LASE WIREFIBER LASER FIBER
GEX
Powered Laser Surgical Instrument
58d
Cleared
Dec 22, 2011
COLLAGEN TENDON SHEET
FTM
Mesh, Surgical
121d
Cleared
Dec 21, 2011
DERMATOLOGICAL TREATMENT DEVICE FAMILY
GEX
Powered Laser Surgical Instrument
226d
Cleared
Dec 20, 2011
DIRECT ANTIBIOTIC INFUSION KIT
LJS
Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
68d
Cleared
Dec 20, 2011
PDS(TM) BARBED SUTURES
NEW
Suture, Surgical, Absorbable, Polydioxanone
74d
Cleared
Dec 20, 2011
UNMIAX LAPAROSCOPIC INSTRUMENT
GEI
Electrosurgical, Cutting & Coagulation & Accessories
386d
Cleared
Dec 19, 2011
ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL
GDW
Staple, Implantable
153d
Cleared
Dec 19, 2011
MX-7000 MICROXEL
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
174d
Cleared
Dec 16, 2011
FIXATE TISSUE BAND
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
29d
Cleared
Dec 16, 2011
TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM
GEX
Powered Laser Surgical Instrument
71d
Cleared
Dec 16, 2011
NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER
NQQ
System, Imaging, Optical Coherence Tomography (oct)
84d
Cleared
Dec 16, 2011
LIQUIBAND FLOW CONTROL
MPN
Tissue Adhesive For The Topical Approximation Of Skin
329d
Cleared
Dec 15, 2011
EXSALT T7 WOUND DRESSING
FRO
Dressing, Wound, Drug
13d
Cleared
Dec 15, 2011
PICO
OMP
Negative Pressure Wound Therapy Powered Suction Pump
233d
Cleared
Dec 13, 2011
SYNTHES HEMOSTATIC BONE PUTTY
MTJ
Wax, Bone
57d
Cleared
Dec 13, 2011
PRECISION SKIN EMULSION
FRO
Dressing, Wound, Drug
232d
Cleared
Dec 09, 2011
CANADY VIEIRA HYBRID PLASMA SCALPEL
GEI
Electrosurgical, Cutting & Coagulation & Accessories
14d
Cleared
Dec 08, 2011
INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES
NAY
System, Surgical, Computer Controlled Instrument
129d
Cleared
Dec 07, 2011
JOULE CLEARSENSE LASER SYSTEM
PDZ
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
190d
Cleared
Dec 07, 2011
DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
247d
Cleared
Dec 07, 2011
3M TEGADERM MATRIX DRESSING
FRO
Dressing, Wound, Drug
293d
Cleared
Dec 07, 2011
DORNIER MEDILAS D LITEBEAM+ 1470
GEX
Powered Laser Surgical Instrument
303d
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