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
13821 General & Plastic Surgery devices
Cleared
Dec 05, 2011
AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER
GEI
Electrosurgical, Cutting & Coagulation & Accessories
168d
Cleared
Dec 01, 2011
SNAP WOUND CARE SYSTEM
OKO
Negative Pressure Wound Therapy Non-powered Suction Apparatus
50d
Cleared
Dec 01, 2011
MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES
NRB
Wound Cleaner, Ultrasound
66d
Cleared
Nov 25, 2011
LIGHT GUIDE CABLE
HBI
Illuminator, Fiberoptic, Surgical Field
196d
Cleared
Nov 22, 2011
RENASYS AB ABOMINAL DRESSING KIT
FTL
Mesh, Surgical, Polymeric
57d
Cleared
Nov 18, 2011
AVO BARRIER TOPICAL EMULSION
FRO
Dressing, Wound, Drug
245d
Cleared
Nov 16, 2011
DENTAL LASER THERAPY SYSTEM
GEX
Powered Laser Surgical Instrument
15d
Cleared
Nov 16, 2011
SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
189d
Cleared
Nov 16, 2011
APOLLO
GEI
Electrosurgical, Cutting & Coagulation & Accessories
217d
Cleared
Nov 15, 2011
REPROCESSED HAND ACTIVATE SEALER/DIVIDER
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
160d
Cleared
Nov 14, 2011
EMERGE FRACTIONAL LASER
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
138d
Cleared
Nov 08, 2011
ENSEAL G2 TISSUS SEALERS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
116d
Cleared
Nov 08, 2011
ACKERMANN EUROPCLIP
FZP
Clip, Implantable
124d
Cleared
Nov 08, 2011
TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC
NEU
Marker, Radiographic, Implantable
145d
Cleared
Nov 03, 2011
ENDOVASCULAR LASER VEIN SYSTEM KIT
GEX
Powered Laser Surgical Instrument
85d
Cleared
Nov 01, 2011
COOLTOUCH
PDZ
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
351d
Cleared
Oct 31, 2011
CLO-SURPLUS P.A.D.
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
27d
Cleared
Oct 27, 2011
FIXATE TISSUE BAND
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
28d
Cleared
Oct 25, 2011
PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF
FTM
Mesh, Surgical
29d
Cleared
Oct 25, 2011
ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS
GDW
Staple, Implantable
119d
Cleared
Oct 25, 2011
SKAFFOLD CIS
MTJ
Wax, Bone
145d
Cleared
Oct 24, 2011
NANOKNIFE SYSTEM
OAB
Low Energy Direct Current Thermal Ablation System
433d
Cleared
Oct 21, 2011
ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE
GEX
Powered Laser Surgical Instrument
85d
Cleared
Oct 20, 2011
LIPSONIX(R) SYSTEM MODEL 2
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
41d
Cleared
Oct 20, 2011
SMART TOUCH UVTHERAPY MULTIPLE MACHINE
FTC
Light, Ultraviolet, Dermatological
202d
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