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
18256
Total
18211
Cleared
136d
Avg (2y)
1976
Since
7636 General & Plastic Surgery devices
Cleared
Jan 29, 2015
Surgical Gut Suture
GAL
Suture, Absorbable, Natural
133d
Cleared
Jan 27, 2015
Ligasure Blunt Tip Sealer/Divider
GEI
Electrosurgical, Cutting & Coagulation & Accessories
110d
Cleared
Jan 23, 2015
CAREFUSION GOLD TISSUE MARKER
NEU
Marker, Radiographic, Implantable
212d
Cleared
Jan 23, 2015
SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS
GEX
Powered Laser Surgical Instrument
228d
Cleared
Jan 21, 2015
Percuvance(R) Percutaneous Surgical System
GCJ
Laparoscope, General & Plastic Surgery
65d
Cleared
Jan 16, 2015
EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
252d
Cleared
Jan 15, 2015
Exilis XP
PBX
Massager, Vacuum, Radio Frequency Induced Heat
85d
Cleared
Jan 13, 2015
PK Cutting Forceps for ESG-400 Workstation
GEI
Electrosurgical, Cutting & Coagulation & Accessories
110d
Cleared
Jan 08, 2015
PK J-HOOK
GEI
Electrosurgical, Cutting & Coagulation & Accessories
139d
Cleared
Dec 31, 2014
PK Spatula
GEI
Electrosurgical, Cutting & Coagulation & Accessories
135d
Cleared
Dec 23, 2014
TISSUE CONTAINMENT SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
116d
Cleared
Dec 22, 2014
HEMASORBPLUS press Resorable Hemostatic Bone Putty
MTJ
Wax, Bone
56d
Cleared
Dec 19, 2014
Force FX-8(S), Force FX-8C(S), Force FX-8CA(S)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
46d
Cleared
Dec 19, 2014
Weck Hem-o-lok Auto Endo5 Ligating Clip Applier
FZP
Clip, Implantable
84d
Cleared
Dec 19, 2014
PK NEEDLE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
135d
Cleared
Dec 15, 2014
ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
GCJ
Laparoscope, General & Plastic Surgery
283d
Cleared
Dec 10, 2014
HICURA HAND INSTRUMENTS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
274d
Cleared
Dec 09, 2014
Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm
GCJ
Laparoscope, General & Plastic Surgery
90d
Cleared
Dec 08, 2014
TWO SKIN TREATMENT SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
185d
Cleared
Dec 03, 2014
12 mm & Stapler Bladeless Obturators
NAY
System, Surgical, Computer Controlled Instrument
23d
Cleared
Dec 02, 2014
Stryker Infrared Fluorescence (IRF) Imaging System
OWN
Confocal Optical Imaging
105d
Cleared
Nov 25, 2014
AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY
JCT
Prosthesis, Tracheal, Expandable
284d
Cleared
Nov 24, 2014
ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
GDW
Staple, Implantable
129d
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
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