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
13857 General & Plastic Surgery devices
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
Cleared
Nov 10, 2008
BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY
GEX
Powered Laser Surgical Instrument
42d
Cleared
Nov 07, 2008
SILS PORT, MODELS SILSPT5, SILSPT12
GCJ
Laparoscope, General & Plastic Surgery
59d
Cleared
Nov 05, 2008
ARTHROCARE ARTHROWANDS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
30d
Cleared
Nov 05, 2008
LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE
GEX
Powered Laser Surgical Instrument
103d
Cleared
Oct 31, 2008
ARAGON ONESHOT SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
175d
Cleared
Oct 30, 2008
CHROMOPHARE E 778 AND E 558
FSY
Light, Surgical, Ceiling Mounted
15d
Cleared
Oct 30, 2008
TEPHAFLEX ABSORBABLE SUTURE
NWJ
Suture, Recombinant Technology
90d
Cleared
Oct 30, 2008
HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GEL
KGN
Wound Dressing With Animal-derived Material(s)
134d
Cleared
Oct 28, 2008
LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS
GEX
Powered Laser Surgical Instrument
41d
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