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
14024 General & Plastic Surgery devices
Cleared
Dec 15, 1999
OMNISONICS ULTRASONIC PROBES
LFL
Instrument, Ultrasonic Surgical
49d
Cleared
Dec 09, 1999
IRIDERM, MODEL APEX 800
GEX
Powered Laser Surgical Instrument
154d
Cleared
Dec 09, 1999
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, SPINE WANDS, ORTHOWANDS, ARTHROWANDS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
129d
Cleared
Dec 09, 1999
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141
LFL
Instrument, Ultrasonic Surgical
87d
Cleared
Dec 09, 1999
XOMED ENT RF SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
83d
Cleared
Dec 06, 1999
SYNTHES LIGHT GUIDE
FQP
Lamp, Operating-room
63d
Cleared
Dec 06, 1999
AED LAPAROSCOPE
GCJ
Laparoscope, General & Plastic Surgery
35d
Cleared
Dec 06, 1999
ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
21d
Cleared
Dec 02, 1999
RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE, DISPERSIVE ELECTRODE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
13d
Cleared
Dec 01, 1999
IMPLANTABLE CLIP FOR GENERAL SURGERY
FZP
Clip, Implantable
72d
Cleared
Nov 24, 1999
ENABLE ENDOSCOPIC BIPOLAR SCISSORS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
78d
Cleared
Nov 23, 1999
STERILE HYDROGEL
MGQ
Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
64d
Cleared
Nov 22, 1999
PILLAR CHIN IMPLANT
FWP
Prosthesis, Chin, Internal
143d
Cleared
Nov 22, 1999
PILLAR MALAR IMPLANT
LZK
Implant, Malar
143d
Cleared
Nov 22, 1999
PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS
FZE
Prosthesis, Nose, Internal
143d
Cleared
Nov 22, 1999
SUTURE CLINCH
GCJ
Laparoscope, General & Plastic Surgery
90d
Cleared
Nov 18, 1999
STAR TEMPORARY WOUND COVER
FTL
Mesh, Surgical, Polymeric
398d
Cleared
Nov 18, 1999
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
JCT
Prosthesis, Tracheal, Expandable
114d
Cleared
Nov 18, 1999
OPTILITE IX LASER SURGERY ACCESSORIES
GEX
Powered Laser Surgical Instrument
85d
Cleared
Nov 18, 1999
AURORA SL
GEX
Powered Laser Surgical Instrument
49d
Cleared
Nov 17, 1999
PHACOLASE ER: YAG LASER
GEX
Powered Laser Surgical Instrument
156d
Cleared
Nov 17, 1999
LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER (3000LE), LASEREX ND:YAG OPHTHALMIC LASER, MODEL
GEX
Powered Laser Surgical Instrument
86d
Cleared
Nov 17, 1999
NON-STICK BIPOLAR FORCEPS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
78d
Cleared
Nov 16, 1999
UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F
GEI
Electrosurgical, Cutting & Coagulation & Accessories
18d
Cleared
Nov 08, 1999
DORNIER SCANNER HANDPIECE
GEX
Powered Laser Surgical Instrument
49d
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