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
18201
Total
18157
Cleared
138d
Avg (2y)
1976
Since
4109 General & Plastic Surgery devices
Cleared
Jun 22, 2011
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD
OMP
Negative Pressure Wound Therapy Powered Suction Pump
107d
Cleared
May 24, 2011
SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM
GDW
Staple, Implantable
29d
Cleared
May 02, 2011
DURAFIBER AG
FRO
Dressing, Wound, Drug
126d
Cleared
Apr 01, 2011
VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM
FTL
Mesh, Surgical, Polymeric
9d
Cleared
Mar 29, 2011
FLEXIVA TRACTIP
GEX
Powered Laser Surgical Instrument
18d
Cleared
Mar 28, 2011
ACCUTRAC
GEX
Powered Laser Surgical Instrument
17d
Cleared
Mar 23, 2011
CELSTAT
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
141d
Cleared
Mar 23, 2011
VENTRALEX ST HERNIA PATCH
FTL
Mesh, Surgical, Polymeric
257d
Cleared
Mar 23, 2011
VENTRIO ST HERNIA PATCH
FTL
Mesh, Surgical, Polymeric
257d
Cleared
Dec 16, 2010
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM
FTL
Mesh, Surgical, Polymeric
83d
Cleared
Sep 29, 2010
FAT CONCENTRATION SYSTEM
MUU
System, Suction, Lipoplasty
257d
Cleared
Sep 17, 2010
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
FTL
Mesh, Surgical, Polymeric
182d
Cleared
Aug 11, 2010
HYBRID TROCAR SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
30d
Cleared
Aug 06, 2010
ENDOSCOPIC CLIP SYSTEM
FZP
Clip, Implantable
11d
Cleared
Aug 06, 2010
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
OMP
Negative Pressure Wound Therapy Powered Suction Pump
22d
Cleared
Jul 30, 2010
ARTHREX BIOWIRE
GAS
Suture, Nonabsorbable, Synthetic, Polyester
477d
Cleared
Jul 14, 2010
AESCULAP MONOMAX ABSORBABLE SUTURE
NWJ
Suture, Recombinant Technology
106d
Cleared
Jun 25, 2010
STRYKER KNIFELIGHT
FTD
Lamp, Surgical
87d
Cleared
May 04, 2010
DERMABOND NX ADHESIVE MODEL: DNX6, DNX12
MPN
Tissue Adhesive For The Topical Approximation Of Skin
77d
Cleared
Apr 21, 2010
VENTRIO HERNIA PATCH
FTL
Mesh, Surgical, Polymeric
85d
Cleared
Apr 07, 2010
ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25
GDW
Staple, Implantable
113d
Cleared
Mar 17, 2010
HARMONY VLED SURGICAL LIGHTNING SYSTEM
FST
Light, Surgical, Fiberoptic
29d
Cleared
Feb 26, 2010
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841
GEI
Electrosurgical, Cutting & Coagulation & Accessories
136d
Cleared
Feb 12, 2010
MODIFIED STRAIGHT FIRE LASER FIBER
GEX
Powered Laser Surgical Instrument
31d
Cleared
Jan 28, 2010
FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT,
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
164d
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