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
13749 General & Plastic Surgery devices
Cleared
May 13, 2014
BIOMARC COAXIAL NEEDLE
FBK
Endoscopic Injection Needle, Gastroenterology-urology
208d
Cleared
May 12, 2014
ZERONA
OLI
Fat Reducing Low Level Laser
159d
Cleared
May 12, 2014
ROSS RU SKIN DISCONTINUITIES
FRO
Dressing, Wound, Drug
382d
Cleared
May 09, 2014
CANDELA GENTLEMAX FAMILY OF LASER SYSTEM
GEX
Powered Laser Surgical Instrument
113d
Cleared
May 09, 2014
SINGLE-SITE PORT
GCJ
Laparoscope, General & Plastic Surgery
204d
Not Cleared
May 09, 2014
PIXEL 3 SYSTEM
PBZ
Image Processing Device For Estimation Of External Blood Loss
459d
Cleared
May 07, 2014
PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH
FTL
Mesh, Surgical, Polymeric
23d
Cleared
May 07, 2014
FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM
OWN
Confocal Optical Imaging
273d
Cleared
May 07, 2014
GORE BIO-A WOUND MATRIX
QSZ
Absorbable Synthetic Wound Dressing
279d
Cleared
May 02, 2014
MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER)
FRO
Dressing, Wound, Drug
130d
Cleared
May 02, 2014
NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE
OMP
Negative Pressure Wound Therapy Powered Suction Pump
305d
Cleared
May 01, 2014
REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
153d
Cleared
May 01, 2014
COLLACARE DENTAL
KGN
Wound Dressing With Animal-derived Material(s)
188d
Cleared
May 01, 2014
SILVERLON ISLAND WOUND DRESSING
FRO
Dressing, Wound, Drug
594d
Cleared
Apr 28, 2014
CAIMAN SEAL AND CUT TECHNOLOGY
GEI
Electrosurgical, Cutting & Coagulation & Accessories
26d
Cleared
Apr 28, 2014
SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE
MPN
Tissue Adhesive For The Topical Approximation Of Skin
59d
Cleared
Apr 28, 2014
XENMATRIX SURGICAL GRAFT
FTM
Mesh, Surgical
60d
Cleared
Apr 28, 2014
SUCTION PUMP
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
112d
Cleared
Apr 28, 2014
EMPRINT ABLATION SYSTEM
NEY
System, Ablation, Microwave And Accessories
133d
Cleared
Apr 28, 2014
PURACYN PLUS SKIN AND WOUND
FRO
Dressing, Wound, Drug
161d
Cleared
Apr 25, 2014
EASY GO VAC
BTA
Pump, Portable, Aspiration (manual Or Powered)
91d
Cleared
Apr 24, 2014
DIODE LASER FOR HIAR REMOVAL
GEX
Powered Laser Surgical Instrument
308d
Cleared
Apr 22, 2014
ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING
GDW
Staple, Implantable
48d
Cleared
Apr 22, 2014
BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE
FRO
Dressing, Wound, Drug
90d
Cleared
Apr 18, 2014
GALAXY CO2 LASER SYSTEM
GEX
Powered Laser Surgical Instrument
116d
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