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
7638 General & Plastic Surgery devices
Cleared
Dec 28, 2011
ENDOWRIST ONE VESSEL SEALER
NAY
System, Surgical, Computer Controlled Instrument
299d
Cleared
Dec 22, 2011
VARI-LASE WIREFIBER LASER FIBER
GEX
Powered Laser Surgical Instrument
58d
Cleared
Dec 20, 2011
PDS(TM) BARBED SUTURES
NEW
Suture, Surgical, Absorbable, Polydioxanone
74d
Cleared
Dec 19, 2011
ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL
GDW
Staple, Implantable
153d
Cleared
Dec 15, 2011
PICO
OMP
Negative Pressure Wound Therapy Powered Suction Pump
233d
Cleared
Dec 08, 2011
INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES
NAY
System, Surgical, Computer Controlled Instrument
129d
Cleared
Dec 07, 2011
3M TEGADERM MATRIX DRESSING
FRO
Dressing, Wound, Drug
293d
Cleared
Dec 07, 2011
DORNIER MEDILAS D LITEBEAM+ 1470
GEX
Powered Laser Surgical Instrument
303d
Cleared
Nov 22, 2011
RENASYS AB ABOMINAL DRESSING KIT
FTL
Mesh, Surgical, Polymeric
57d
Cleared
Oct 24, 2011
NANOKNIFE SYSTEM
OAB
Low Energy Direct Current Thermal Ablation System
433d
Cleared
Oct 07, 2011
MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY
NAY
System, Surgical, Computer Controlled Instrument
60d
Cleared
Oct 07, 2011
RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
KAM
Cannula, Sinus
210d
Cleared
Oct 05, 2011
CANDELA GENTLEMAX FAMILY OF LASERS
GEX
Powered Laser Surgical Instrument
16d
Cleared
Oct 04, 2011
ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
GCJ
Laparoscope, General & Plastic Surgery
40d
Cleared
Sep 29, 2011
5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT
NAY
System, Surgical, Computer Controlled Instrument
23d
Cleared
Sep 09, 2011
CLOSUREFAST RADIOFREQUENCY CATHETER
GEI
Electrosurgical, Cutting & Coagulation & Accessories
70d
Cleared
Aug 26, 2011
ENDOWRIST ONE SUCTION/IRRIGATOR
NAY
System, Surgical, Computer Controlled Instrument
191d
Cleared
Aug 25, 2011
YOULASER CO2 LASER SYSTEM
GEX
Powered Laser Surgical Instrument
79d
Cleared
Aug 11, 2011
PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)
FTL
Mesh, Surgical, Polymeric
156d
Cleared
Aug 03, 2011
ATRICURE CRYO MODULE SYSTEM
GEH
Unit, Cryosurgical, Accessories
14d
Cleared
Aug 03, 2011
VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
GDW
Staple, Implantable
97d
Cleared
Jul 25, 2011
VISION ONE LASER SYSTEM
GEX
Powered Laser Surgical Instrument
84d
Cleared
Jul 18, 2011
CANDELA GENTLELASE FAMILY OF LASERS
GEX
Powered Laser Surgical Instrument
87d
Cleared
Jun 28, 2011
BIPOLAR HF DEVICE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
106d
Cleared
Jun 22, 2011
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD
OMP
Negative Pressure Wound Therapy Powered Suction Pump
107d
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