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
13971 General & Plastic Surgery devices
Cleared
Nov 30, 2004
SURGICAL DRAPE KIT - D.I.R.R.A. SRL
LRO
General Surgery Tray
218d
Cleared
Nov 30, 2004
DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD
FSY
Light, Surgical, Ceiling Mounted
90d
Cleared
Nov 24, 2004
MUCOTROL CONCENTRATED ORAL GEL WAFER
OLR
Oral Wound Dressing
82d
Cleared
Nov 24, 2004
MCL 30 DERMABLATE ER:YAG LASER SYSTEM
GEX
Powered Laser Surgical Instrument
27d
Cleared
Nov 22, 2004
CANDELA SMOOTHBEAM LASER SYSTEM
GEX
Powered Laser Surgical Instrument
195d
Cleared
Nov 22, 2004
MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2
GEX
Powered Laser Surgical Instrument
31d
Cleared
Nov 19, 2004
IMALUX NIRIS IMAGING SYSTEM
NQQ
System, Imaging, Optical Coherence Tomography (oct)
30d
Cleared
Nov 19, 2004
AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE
GAL
Suture, Absorbable, Natural
30d
Cleared
Nov 17, 2004
PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA
GEX
Powered Laser Surgical Instrument
183d
Cleared
Nov 17, 2004
SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
16d
Cleared
Nov 17, 2004
OMNIPULSE MINI, MODEL 2120
GEX
Powered Laser Surgical Instrument
15d
Cleared
Nov 12, 2004
GENICON SUCTION IRRIGATION SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
114d
Cleared
Nov 12, 2004
COOL-TIP RF ABLATION SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
88d
Cleared
Nov 12, 2004
INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT
NAY
System, Surgical, Computer Controlled Instrument
28d
Cleared
Nov 12, 2004
STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A
GEI
Electrosurgical, Cutting & Coagulation & Accessories
22d
Cleared
Nov 09, 2004
SURGICHIP TAG SURGICAL MARKER
FZZ
Marker, Skin
50d
Cleared
Nov 08, 2004
POLARIS DS/COMET
GEX
Powered Laser Surgical Instrument
110d
Cleared
Nov 08, 2004
MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS
GEX
Powered Laser Surgical Instrument
84d
Cleared
Nov 08, 2004
VIVOSORB SHEET, MODEL FS01
FTL
Mesh, Surgical, Polymeric
27d
Cleared
Nov 03, 2004
GENICON BIPOLAR FORCEPS MODEL # 600-005-005
GEI
Electrosurgical, Cutting & Coagulation & Accessories
105d
Cleared
Nov 02, 2004
3M TEGADERM SILVER
FRO
Dressing, Wound, Drug
223d
Cleared
Nov 02, 2004
ADEPT ULTRALITE 532 LASER
GEX
Powered Laser Surgical Instrument
49d
Cleared
Nov 02, 2004
CUFFPATCH
FTM
Mesh, Surgical
21d
Cleared
Nov 01, 2004
INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
91d
Cleared
Nov 01, 2004
VERSATILE 1 WOUND VACUUM SYSTEM
OMP
Negative Pressure Wound Therapy Powered Suction Pump
84d
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