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
13841 General & Plastic Surgery devices
Cleared
Dec 04, 2008
INTEGRA MESHED BILAYER WOUND MATRIX
KGN
Wound Dressing With Animal-derived Material(s)
176d
Cleared
Dec 03, 2008
PULSAR GENERATOR, PEAK PLASMABLADE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
71d
Cleared
Dec 03, 2008
NO!NO! SKIN
GEX
Powered Laser Surgical Instrument
103d
Cleared
Dec 03, 2008
15W CERALAS D 1470NM DIODE LASER, MODEL D1470
GEX
Powered Laser Surgical Instrument
119d
Cleared
Dec 01, 2008
COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
90d
Cleared
Dec 01, 2008
DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER
NAC
Dressing, Wound, Hydrophilic
118d
Cleared
Dec 01, 2008
PROSIT WOUND TREATMENT DEVICE
FRO
Dressing, Wound, Drug
143d
Cleared
Nov 26, 2008
VERITAS COLLAGEN MATRIX (DRY)
FTM
Mesh, Surgical
43d
Cleared
Nov 25, 2008
PRODIGY NPWT SYSTEM MODEL PRODIGY 800V
OMP
Negative Pressure Wound Therapy Powered Suction Pump
96d
Cleared
Nov 25, 2008
VALLEYLAB MICROWAVE ABLATION GENERATOR
NEY
System, Ablation, Microwave And Accessories
428d
Cleared
Nov 21, 2008
REXASTOM ORAL EASE
OLR
Oral Wound Dressing
79d
Cleared
Nov 21, 2008
VERTEBRAL ACCESS SYSTEM BY VIDACARE
MOQ
Battery, Replacement, Rechargeable
157d
Cleared
Nov 20, 2008
AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM
JCT
Prosthesis, Tracheal, Expandable
101d
Cleared
Nov 17, 2008
SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
74d
Cleared
Nov 14, 2008
ULTRAWAVE III EX 1320
GEX
Powered Laser Surgical Instrument
14d
Cleared
Nov 14, 2008
AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS
GCJ
Laparoscope, General & Plastic Surgery
93d
Cleared
Nov 14, 2008
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
OMP
Negative Pressure Wound Therapy Powered Suction Pump
100d
Cleared
Nov 14, 2008
LTM-BPS SURGICAL MESH
FTM
Mesh, Surgical
105d
Cleared
Nov 14, 2008
TANDA SKINCARE SYSTEM, MODEL: PTSCS
GEX
Powered Laser Surgical Instrument
256d
Cleared
Nov 13, 2008
EZLASE 10W
GEX
Powered Laser Surgical Instrument
29d
Cleared
Nov 13, 2008
SERISCAFFOLD SURGICAL MESH
FTL
Mesh, Surgical, Polymeric
268d
Cleared
Nov 12, 2008
D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015
QSX
Hemostatic Wound Dressing With Thrombin Or Other Biologics
14d
Cleared
Nov 12, 2008
AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
51d
Cleared
Nov 12, 2008
BENACEL, MODELS C-001, C-002 AND C-005
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
260d
Cleared
Nov 12, 2008
SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING
FRO
Dressing, Wound, Drug
261d
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