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
14005 General & Plastic Surgery devices
Cleared
Dec 09, 2002
AMSINO TRACHEOSTOMY CARE TRAY
LRO
General Surgery Tray
69d
Cleared
Dec 06, 2002
FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM
GEX
Powered Laser Surgical Instrument
207d
Cleared
Dec 05, 2002
CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20
GEH
Unit, Cryosurgical, Accessories
27d
Cleared
Dec 02, 2002
V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT
OMP
Negative Pressure Wound Therapy Powered Suction Pump
207d
Cleared
Nov 29, 2002
UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
17d
Cleared
Nov 29, 2002
NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20193-084 AND P/N: 20193-085
GEI
Electrosurgical, Cutting & Coagulation & Accessories
14d
Cleared
Nov 25, 2002
FOTONA TANDEM LASER SYSTEM
GEX
Powered Laser Surgical Instrument
90d
Cleared
Nov 25, 2002
FOTONA DUALIS ER:YAG/KTP LASER SYSTEM
GEX
Powered Laser Surgical Instrument
90d
Cleared
Nov 25, 2002
FOTONA DUALIS PLUS ND:YAG LASER SYSTEM
GEX
Powered Laser Surgical Instrument
90d
Cleared
Nov 22, 2002
COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II
GEX
Powered Laser Surgical Instrument
88d
Cleared
Nov 20, 2002
CYNOSURE PHOTOGENICA SV
GEX
Powered Laser Surgical Instrument
198d
Cleared
Nov 19, 2002
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
GDW
Staple, Implantable
252d
Cleared
Nov 18, 2002
MILLENNIUM MICROSURGICAL SYSTEM
GEX
Powered Laser Surgical Instrument
90d
Cleared
Nov 15, 2002
HERMES OPERATING ROOM CONTROL CENTER
GCJ
Laparoscope, General & Plastic Surgery
58d
Cleared
Nov 13, 2002
STELLAR SERIES SURGICAL LIGHTS WITH HERMES
FSY
Light, Surgical, Ceiling Mounted
183d
Cleared
Nov 13, 2002
MICROVASIVE PULMONARY GUIDEWIRE
MDM
Instrument, Manual, Surgical, General Use
141d
Cleared
Nov 12, 2002
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/1200
NAY
System, Surgical, Computer Controlled Instrument
102d
Cleared
Nov 12, 2002
ESSEX ENDOSCOPE, MODEL SXD-1000
GCJ
Laparoscope, General & Plastic Surgery
15d
Cleared
Nov 07, 2002
ARTHREX FIBERWIRE IN USP SIZES
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
185d
Cleared
Nov 07, 2002
TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH
GEX
Powered Laser Surgical Instrument
90d
Cleared
Nov 05, 2002
THERMAGE THERMACOOL TC SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
187d
Cleared
Nov 04, 2002
AUTOCON II 400 ELECTROSURGICAL GENERATOR
GEI
Electrosurgical, Cutting & Coagulation & Accessories
181d
Cleared
Oct 30, 2002
LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES
GEX
Powered Laser Surgical Instrument
127d
Cleared
Oct 25, 2002
DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM
GEX
Powered Laser Surgical Instrument
266d
Cleared
Oct 24, 2002
INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS
GEX
Powered Laser Surgical Instrument
30d
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