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
13853 General & Plastic Surgery devices
Cleared
Jan 09, 2009
180W CERELAS D 980NM DIODE LASER, MODEL D180
GEX
Powered Laser Surgical Instrument
29d
Cleared
Jan 09, 2009
REPROCESSED HARMONIC SCALPEL
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
87d
Cleared
Jan 08, 2009
MODIFICATION TO ZENIEVA
NAE
Dressing, Wound, Hydrogel Without Drug And/or Biologic
24d
Cleared
Jan 07, 2009
BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215
FTL
Mesh, Surgical, Polymeric
97d
Cleared
Jan 02, 2009
DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087
GDW
Staple, Implantable
136d
Cleared
Jan 02, 2009
A-LAP SET (A-LAP, EZAXESS, TROCAR)
GCJ
Laparoscope, General & Plastic Surgery
144d
Cleared
Dec 31, 2008
ERBE MODEL VIO 300 D WITH ACCESSORIES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
40d
Cleared
Dec 29, 2008
WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553
FRO
Dressing, Wound, Drug
46d
Cleared
Dec 24, 2008
FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5
GAQ
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
254d
Cleared
Dec 23, 2008
FIXATION TROCARS
GCJ
Laparoscope, General & Plastic Surgery
14d
Cleared
Dec 23, 2008
QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY
GEX
Powered Laser Surgical Instrument
15d
Cleared
Dec 22, 2008
NOVEON MODEL LS1100-03
GEX
Powered Laser Surgical Instrument
28d
Cleared
Dec 22, 2008
EZLASE
GEX
Powered Laser Surgical Instrument
81d
Cleared
Dec 19, 2008
SURGISEAL TOPICAL SKIN ADHESIVE
MPN
Tissue Adhesive For The Topical Approximation Of Skin
73d
Cleared
Dec 19, 2008
SMOOTHCOOL HR SYSTEM
GEX
Powered Laser Surgical Instrument
80d
Cleared
Dec 19, 2008
3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
99d
Cleared
Dec 19, 2008
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE
NAY
System, Surgical, Computer Controlled Instrument
234d
Cleared
Dec 18, 2008
INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS
GDW
Staple, Implantable
20d
Cleared
Dec 18, 2008
WOUND FLUSH, STERILE WATER & NORMAL SALINE
FRO
Dressing, Wound, Drug
65d
Cleared
Dec 18, 2008
ALPHA ORTHOPAEDICS AT2 SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
76d
Cleared
Dec 18, 2008
ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM
GEX
Powered Laser Surgical Instrument
85d
Cleared
Dec 18, 2008
GENADYNE A4 WOUND VACUUM SYSTEM
OMP
Negative Pressure Wound Therapy Powered Suction Pump
94d
Cleared
Dec 18, 2008
VIKY
GCJ
Laparoscope, General & Plastic Surgery
133d
Cleared
Dec 17, 2008
ML24000 UVA-1 PHOTOTHERAPY CABINET
FTC
Light, Ultraviolet, Dermatological
90d
Cleared
Dec 17, 2008
GRAFTGUARD PRESSURE CONTROLLING SYRINGE
GBX
Catheter, Irrigation
91d
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