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
18256
Total
18211
Cleared
137d
Avg (2y)
1976
Since
7667 General & Plastic Surgery devices
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 13, 2002
MICROVASIVE PULMONARY GUIDEWIRE
MDM
Instrument, Manual, Surgical, General Use
141d
Cleared
Nov 12, 2002
ESSEX ENDOSCOPE, MODEL SXD-1000
GCJ
Laparoscope, General & Plastic Surgery
15d
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 07, 2002
TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH
GEX
Powered Laser Surgical Instrument
90d
Cleared
Nov 07, 2002
ARTHREX FIBERWIRE IN USP SIZES
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
185d
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
Cleared
Oct 17, 2002
COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X
GEI
Electrosurgical, Cutting & Coagulation & Accessories
15d
Cleared
Oct 16, 2002
NOVUS SPECTRA
GEX
Powered Laser Surgical Instrument
90d
Cleared
Oct 11, 2002
QUANTUM, MODELS SR, HR, DL
GEX
Powered Laser Surgical Instrument
210d
Cleared
Oct 04, 2002
CANDELA SMOOTHBEAM LASER SYSTEM
GEX
Powered Laser Surgical Instrument
291d
Cleared
Oct 04, 2002
CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)
MGQ
Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
346d
Cleared
Oct 03, 2002
DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
20d
Cleared
Oct 03, 2002
MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
66d
Cleared
Oct 03, 2002
AURORA SR
GEX
Powered Laser Surgical Instrument
83d
Cleared
Oct 01, 2002
NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES
GEX
Powered Laser Surgical Instrument
90d
Cleared
Sep 23, 2002
RMNIPULSE HOLMIUM LASER SYSTEM/1210
GEX
Powered Laser Surgical Instrument
294d
Cleared
Sep 13, 2002
COATED VICRYL* (POLYGLACTIN 910) SUTURE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
60d
Cleared
Sep 10, 2002
DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
FTL
Mesh, Surgical, Polymeric
19d
Cleared
Aug 28, 2002
PRECISION PLUS TUNA OFFICE SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
86d
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