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
136d
Avg (2y)
1976
Since
7652 General & Plastic Surgery devices
Cleared
May 27, 2005
VANGUARD REPROCESSED ARTHROSCOPIC WANDS
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
190d
Cleared
May 27, 2005
MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE
GAQ
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
245d
Cleared
May 26, 2005
V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
OMP
Negative Pressure Wound Therapy Powered Suction Pump
111d
Cleared
May 25, 2005
SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX
GEI
Electrosurgical, Cutting & Coagulation & Accessories
44d
Cleared
May 17, 2005
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER
GDW
Staple, Implantable
27d
Cleared
May 17, 2005
ADVANCED TURBO DRIVE SYSTEM
GEY
Motor, Surgical Instrument, Ac-powered
77d
Cleared
May 16, 2005
ARMAND ENDOSCOPE HOLDER
GCJ
Laparoscope, General & Plastic Surgery
126d
Cleared
May 06, 2005
ATRIUM ICAST COVERED STENT
JCT
Prosthesis, Tracheal, Expandable
36d
Cleared
May 05, 2005
CYNOSUREA ECLILITE AND ECLILITE U
FTC
Light, Ultraviolet, Dermatological
112d
Cleared
Apr 29, 2005
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
NAY
System, Surgical, Computer Controlled Instrument
74d
Cleared
Apr 21, 2005
ACTICOAT MOISTURE CONTROL DRESSING
FRO
Dressing, Wound, Drug
104d
Cleared
Apr 14, 2005
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
QSX
Hemostatic Wound Dressing With Thrombin Or Other Biologics
44d
Cleared
Apr 12, 2005
AURORA DS, DS APPLICATOR
GEX
Powered Laser Surgical Instrument
14d
Cleared
Apr 12, 2005
REPROCESSED HARMONIC SCALPELS
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
60d
Cleared
Apr 08, 2005
LUPINE LOOP
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
14d
Cleared
Mar 24, 2005
MEGA POWER ELECTROSURGICAL GENERATOR
GEI
Electrosurgical, Cutting & Coagulation & Accessories
17d
Cleared
Mar 22, 2005
VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
111d
Cleared
Mar 22, 2005
VANGUARD REPROCESSED ULTRASONIC SCALPEL
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
120d
Cleared
Mar 18, 2005
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
GEX
Powered Laser Surgical Instrument
72d
Cleared
Mar 14, 2005
VAPORMAX
GEX
Powered Laser Surgical Instrument
24d
Cleared
Mar 14, 2005
MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
28d
Cleared
Mar 14, 2005
LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER
FZP
Clip, Implantable
31d
Cleared
Mar 09, 2005
AURORA SR AND SRA APPLICATOR
GEX
Powered Laser Surgical Instrument
15d
Cleared
Mar 03, 2005
MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
NAY
System, Surgical, Computer Controlled Instrument
94d
Cleared
Feb 23, 2005
QUADRANT RETRACTOR SYSTEM
GAD
Retractor
56d
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