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
13702 General & Plastic Surgery devices
Cleared
Nov 06, 2015
Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing
OMP
Negative Pressure Wound Therapy Powered Suction Pump
308d
Cleared
Nov 05, 2015
BD ChloraShield IV Dressing with CHG Antimicrobial
FRO
Dressing, Wound, Drug
31d
Cleared
Nov 05, 2015
AnsCare ChitoClot Pad
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
209d
Cleared
Nov 02, 2015
Bovie J-Plasma Precise 360 Handpiece
GEI
Electrosurgical, Cutting & Coagulation & Accessories
54d
Cleared
Nov 02, 2015
Avance Y-Connector S
OMP
Negative Pressure Wound Therapy Powered Suction Pump
116d
Cleared
Nov 02, 2015
PGA RESORBA, PGA RESOQUICK, GLYCOLON
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
319d
Cleared
Oct 30, 2015
Cosmedico Ultraviolet Lamps of Various Models
LEJ
Booth, Sun Tan
79d
Cleared
Oct 30, 2015
Lumenis Smart532 Laser System
GEX
Powered Laser Surgical Instrument
186d
Cleared
Oct 30, 2015
Elliquence Electrodes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
428d
Cleared
Oct 29, 2015
OPTIS Mobile System
NQQ
System, Imaging, Optical Coherence Tomography (oct)
91d
Cleared
Oct 29, 2015
ALAR Nasal Valve Stent
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
122d
Cleared
Oct 29, 2015
MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
315d
Cleared
Oct 28, 2015
RiverLon (Nylon) Suture
GAR
Suture, Nonabsorbable, Synthetic, Polyamide
30d
Cleared
Oct 28, 2015
VS3-IR system
OWN
Confocal Optical Imaging
83d
Cleared
Oct 28, 2015
Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps)
LEJ
Booth, Sun Tan
92d
Cleared
Oct 27, 2015
Guardian 1000
GEX
Powered Laser Surgical Instrument
132d
Cleared
Oct 27, 2015
ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe
GEI
Electrosurgical, Cutting & Coagulation & Accessories
343d
Cleared
Oct 26, 2015
Retrieval bag system
GCJ
Laparoscope, General & Plastic Surgery
146d
Cleared
Oct 26, 2015
LiquiBand Exceed
MPN
Tissue Adhesive For The Topical Approximation Of Skin
175d
Cleared
Oct 23, 2015
Cellvizio 100 Series System with Confocal Miniprobes
OWN
Confocal Optical Imaging
133d
Cleared
Oct 23, 2015
LightStim Professional 2-Panel Light
OHS
Light Based Over The Counter Wrinkle Reduction
157d
Cleared
Oct 23, 2015
SureClip
FZP
Clip, Implantable
199d
Cleared
Oct 23, 2015
RF20000a Controller, FLOW 50 Wand
GEI
Electrosurgical, Cutting & Coagulation & Accessories
347d
Cleared
Oct 22, 2015
DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive
MPN
Tissue Adhesive For The Topical Approximation Of Skin
86d
Cleared
Oct 22, 2015
C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic
FTL
Mesh, Surgical, Polymeric
149d
Looking for a specific general & plastic surgery device? Search by device name, K-number or manufacturer.
Search all General & Plastic Surgery 510(k) devices