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
13735 General & Plastic Surgery devices
Cleared
Nov 19, 2014
EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable
GEI
Electrosurgical, Cutting & Coagulation & Accessories
33d
Cleared
Nov 14, 2014
Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh
FTL
Mesh, Surgical, Polymeric
39d
Cleared
Nov 14, 2014
WEGO-PGCL Absorbable Surgical Monofilament Suture
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
46d
Cleared
Nov 14, 2014
V20 SYSTEM
GEX
Powered Laser Surgical Instrument
105d
Cleared
Nov 13, 2014
UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH
GCJ
Laparoscope, General & Plastic Surgery
153d
Cleared
Nov 13, 2014
REJUVALITE MD
OHS
Light Based Over The Counter Wrinkle Reduction
328d
Cleared
Nov 12, 2014
neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US
GCJ
Laparoscope, General & Plastic Surgery
37d
Cleared
Nov 07, 2014
SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING
FRO
Dressing, Wound, Drug
21d
Cleared
Nov 07, 2014
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
GEX
Powered Laser Surgical Instrument
228d
Cleared
Nov 07, 2014
CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4
FRO
Dressing, Wound, Drug
266d
Cleared
Nov 06, 2014
CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
LFL
Instrument, Ultrasonic Surgical
136d
Cleared
Nov 06, 2014
CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
LFL
Instrument, Ultrasonic Surgical
136d
Cleared
Nov 06, 2014
ADVANTAGE
GEX
Powered Laser Surgical Instrument
147d
Cleared
Nov 06, 2014
CUTERA PICOSECOND LASER SYSTEM
GEX
Powered Laser Surgical Instrument
227d
Cleared
Nov 05, 2014
LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400
NQK
Maggots, Medical
103d
Cleared
Oct 31, 2014
NS3000 Holmium Laser System
GEX
Powered Laser Surgical Instrument
74d
Cleared
Oct 31, 2014
NAWALUTION SKIN AND WOUND CLEANSER
FRO
Dressing, Wound, Drug
133d
Cleared
Oct 31, 2014
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
302d
Cleared
Oct 30, 2014
Premium Surgiclip III
FZP
Clip, Implantable
29d
Cleared
Oct 30, 2014
Pico Way Laser System
GEX
Powered Laser Surgical Instrument
66d
Cleared
Oct 29, 2014
Leo Minor
FSY
Light, Surgical, Ceiling Mounted
13d
Cleared
Oct 29, 2014
cryoICE croablation probe
GEH
Unit, Cryosurgical, Accessories
57d
Cleared
Oct 28, 2014
Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh
FTL
Mesh, Surgical, Polymeric
22d
Cleared
Oct 28, 2014
SMARTGRAFT 200 SYSTEM
MUU
System, Suction, Lipoplasty
125d
Cleared
Oct 28, 2014
ALLOX2 TISSUE EXPANDERS
LCJ
Tissue Expander And Accessories
256d
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