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
13964 General & Plastic Surgery devices
Cleared
May 02, 2005
ERCHONIA EVRL LASER
GEX
Powered Laser Surgical Instrument
48d
Cleared
Apr 29, 2005
DIODENT II DENTAL LASER SYSTEM
GEX
Powered Laser Surgical Instrument
81d
Cleared
Apr 29, 2005
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
NAY
System, Surgical, Computer Controlled Instrument
74d
Cleared
Apr 29, 2005
MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS
GEX
Powered Laser Surgical Instrument
14d
Cleared
Apr 27, 2005
AIP INTENSE PULSED LIGHT SYSTEM
GEX
Powered Laser Surgical Instrument
321d
Cleared
Apr 27, 2005
COLACTIVE COLLAGEN WOUND DRESSING
KGN
Wound Dressing With Animal-derived Material(s)
91d
Cleared
Apr 27, 2005
MICROMEDICS SPHENOID SINUS STENT
KAM
Cannula, Sinus
75d
Cleared
Apr 26, 2005
APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
GAD
Retractor
82d
Cleared
Apr 21, 2005
ACTICOAT MOISTURE CONTROL DRESSING
FRO
Dressing, Wound, Drug
104d
Cleared
Apr 19, 2005
MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100
GEX
Powered Laser Surgical Instrument
84d
Cleared
Apr 19, 2005
FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT
FTC
Light, Ultraviolet, Dermatological
32d
Cleared
Apr 15, 2005
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
143d
Cleared
Apr 15, 2005
SPECTRA-SP CO2 LASER SYSTEM
GEX
Powered Laser Surgical Instrument
71d
Cleared
Apr 14, 2005
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
QSX
Hemostatic Wound Dressing With Thrombin Or Other Biologics
44d
Cleared
Apr 14, 2005
OCULIGHT GL/GLX
GEX
Powered Laser Surgical Instrument
42d
Cleared
Apr 14, 2005
QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
20d
Cleared
Apr 12, 2005
REPROCESSED HARMONIC SCALPELS
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
60d
Cleared
Apr 12, 2005
AURORA DS, DS APPLICATOR
GEX
Powered Laser Surgical Instrument
14d
Cleared
Apr 12, 2005
STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A
GEI
Electrosurgical, Cutting & Coagulation & Accessories
11d
Cleared
Apr 08, 2005
TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
305d
Cleared
Apr 08, 2005
LUPINE LOOP
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
14d
Cleared
Apr 07, 2005
SURGITRON RADIOLASE II
GEI
Electrosurgical, Cutting & Coagulation & Accessories
189d
Cleared
Apr 06, 2005
DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
105d
Cleared
Apr 06, 2005
ENDOTINE RIBBON
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
28d
Cleared
Apr 01, 2005
CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
30d
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