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
13956 General & Plastic Surgery devices
Cleared
Jan 13, 2005
PALOMAR LUX1064 HANDPIECE
GEX
Powered Laser Surgical Instrument
185d
Cleared
Jan 13, 2005
ALOCLAIR ORAL SPRAY
OLR
Oral Wound Dressing
104d
Cleared
Jan 12, 2005
CYNERGY LASER
GEX
Powered Laser Surgical Instrument
30d
Cleared
Jan 07, 2005
MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR
BTA
Pump, Portable, Aspiration (manual Or Powered)
15d
Cleared
Jan 05, 2005
LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
40d
Cleared
Dec 27, 2004
UNICRYL
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
125d
Cleared
Dec 23, 2004
MTF ALLOGRAFT ANCHOR
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
147d
Cleared
Dec 22, 2004
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
FTL
Mesh, Surgical, Polymeric
47d
Cleared
Dec 22, 2004
GORE POLYPROPYLENE HERNIA MESH
FTL
Mesh, Surgical, Polymeric
44d
Cleared
Dec 21, 2004
SERFAS ENERGY SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
168d
Cleared
Dec 21, 2004
MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS
GEX
Powered Laser Surgical Instrument
148d
Cleared
Dec 21, 2004
NOVASYS TRANSURETHRAL RF SYSTEM
NVJ
Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
134d
Cleared
Dec 21, 2004
CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884
GEI
Electrosurgical, Cutting & Coagulation & Accessories
22d
Cleared
Dec 17, 2004
MD-6W WIRELESS CRITICAL DATA VIEWER
GCJ
Laparoscope, General & Plastic Surgery
56d
Cleared
Dec 17, 2004
NOUVAG AG - VACUSON 40 AND VACUSON 60
BTA
Pump, Portable, Aspiration (manual Or Powered)
53d
Cleared
Dec 17, 2004
CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES
GEX
Powered Laser Surgical Instrument
15d
Cleared
Dec 17, 2004
PERMACOL SURGICAL IMPLANT
FTL
Mesh, Surgical, Polymeric
9d
Cleared
Dec 16, 2004
OPUSDUO
GEX
Powered Laser Surgical Instrument
315d
Cleared
Dec 16, 2004
EMG MODEL SUA01 SUCTION UNIT
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
108d
Cleared
Dec 15, 2004
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000
NAY
System, Surgical, Computer Controlled Instrument
30d
Cleared
Dec 14, 2004
MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
GEX
Powered Laser Surgical Instrument
69d
Cleared
Dec 10, 2004
ARTHREX SUTURE GRAFTING KIT
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
184d
Cleared
Dec 10, 2004
UNICRYL M
NEW
Suture, Surgical, Absorbable, Polydioxanone
108d
Cleared
Dec 10, 2004
PANALIGHT-BLU, MODEL 4175
GEX
Powered Laser Surgical Instrument
24d
Cleared
Dec 10, 2004
BLUE ORTHOCORD SUTURE
NEW
Suture, Surgical, Absorbable, Polydioxanone
10d
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