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
7632 General & Plastic Surgery devices
Cleared
Aug 13, 2015
Stryker Suture Tape
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
157d
Cleared
Aug 04, 2015
Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot
GEI
Electrosurgical, Cutting & Coagulation & Accessories
137d
Cleared
Jul 28, 2015
Barrx Anorectal RFA Wand
GEI
Electrosurgical, Cutting & Coagulation & Accessories
175d
Cleared
Jul 23, 2015
RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device
OMP
Negative Pressure Wound Therapy Powered Suction Pump
265d
Cleared
Jul 21, 2015
Caiman Seal and Cut Technology
GEI
Electrosurgical, Cutting & Coagulation & Accessories
13d
Cleared
Jul 20, 2015
Caiman Seal and Cut Technology
GEI
Electrosurgical, Cutting & Coagulation & Accessories
27d
Cleared
Jul 17, 2015
ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks
GDW
Staple, Implantable
28d
Cleared
Jul 16, 2015
RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device
OMP
Negative Pressure Wound Therapy Powered Suction Pump
59d
Cleared
Jul 10, 2015
HARMONIC Focus Long Shears + Adaptive Tissue Technology
LFL
Instrument, Ultrasonic Surgical
52d
Cleared
Jul 02, 2015
VersaOne Bladed Trocar, VersaOne Bladeless Trocar
GCJ
Laparoscope, General & Plastic Surgery
23d
Cleared
Jul 02, 2015
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
NEW
Suture, Surgical, Absorbable, Polydioxanone
108d
Cleared
Jul 01, 2015
SculpSure
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
103d
Cleared
Jun 18, 2015
Spacemaker Pro Access and Dissector System
GCJ
Laparoscope, General & Plastic Surgery
29d
Cleared
Jun 18, 2015
NanoKnife System
OAB
Low Energy Direct Current Thermal Ablation System
153d
Cleared
Jun 17, 2015
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
FZP
Clip, Implantable
63d
Cleared
Jun 16, 2015
Edwards Suture Fastening System
HCF
Instrument, Ligature Passing And Knot Tying
75d
Cleared
Jun 11, 2015
XP1000 RF
GEI
Electrosurgical, Cutting & Coagulation & Accessories
177d
Cleared
Jun 05, 2015
Phasix ST Mesh
OWT
Mesh, Surgical, Absorbable, Abdominal Hernia
192d
Cleared
May 29, 2015
Signia Loading Unit, Tri-Staple 2.0 Cartridge
GDW
Staple, Implantable
28d
Cleared
May 26, 2015
Versatex Monofilament Mesh
FTL
Mesh, Surgical, Polymeric
130d
Cleared
May 20, 2015
Reprocessed Cordless Ultrasonic Dissection Device
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
155d
Cleared
May 18, 2015
Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler
GDW
Staple, Implantable
131d
Cleared
May 15, 2015
IS4000 da Vinci EndoWrist Instruments
NAY
System, Surgical, Computer Controlled Instrument
99d
Cleared
May 15, 2015
SculpSure
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
102d
Cleared
May 04, 2015
ERBECRYO 2 Cryosurgical Unit with accessories
GEH
Unit, Cryosurgical, Accessories
14d
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