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
13752 General & Plastic Surgery devices
Cleared
May 14, 2013
ATRICLIP GILLINOV-COSGROVE LAA CLIP
FZP
Clip, Implantable
25d
Cleared
May 13, 2013
AG MASS
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
24d
Cleared
May 10, 2013
STINGRAY BIPOLAR FORCEPS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
178d
Cleared
May 08, 2013
BEACON TISSUE MARKER
NEU
Marker, Radiographic, Implantable
49d
Cleared
May 08, 2013
VOLISTA 400
FTD
Lamp, Surgical
70d
Cleared
May 07, 2013
TEPHAFLEX MELTBLOWN CONSTRUCT
OOD
Surgical Film
88d
Cleared
May 03, 2013
QYAG LASER SYSTEM
GEX
Powered Laser Surgical Instrument
91d
Cleared
May 02, 2013
WATERLASE IPLUS ALL TISSUE LASER
GEX
Powered Laser Surgical Instrument
269d
Cleared
May 01, 2013
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
FTL
Mesh, Surgical, Polymeric
23d
Cleared
May 01, 2013
HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM
FRO
Dressing, Wound, Drug
250d
Cleared
Apr 25, 2013
SERI SURGICAL SCAFFOLD
OXF
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
203d
Cleared
Apr 25, 2013
NVISION VLE IMAGING SYSTEM
NQQ
System, Imaging, Optical Coherence Tomography (oct)
405d
Cleared
Apr 24, 2013
SURGISEAL TOPICAL SKIN ADHESIVE
MPN
Tissue Adhesive For The Topical Approximation Of Skin
125d
Cleared
Apr 21, 2013
DIODE LASER
GEX
Powered Laser Surgical Instrument
159d
Cleared
Apr 21, 2013
FIBRILLAR COLLAGEN WOUND DRESSING
KGN
Wound Dressing With Animal-derived Material(s)
450d
Cleared
Apr 18, 2013
ENDO GIA RELOAD
GDW
Staple, Implantable
34d
Cleared
Apr 18, 2013
HYDRASOLVE LIPOPLASTY SYSTEM
MUU
System, Suction, Lipoplasty
86d
Cleared
Apr 18, 2013
CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
OWN
Confocal Optical Imaging
139d
Cleared
Apr 18, 2013
NEOCLOSE HASSON, NEOCLOSE UNIVERSAL
GCJ
Laparoscope, General & Plastic Surgery
178d
Cleared
Apr 18, 2013
A3F FRATIONAL
GEI
Electrosurgical, Cutting & Coagulation & Accessories
267d
Cleared
Apr 18, 2013
BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)
PDT
Burn Resuscitation Decision Support Software
317d
Cleared
Apr 17, 2013
LTN - LAPAROSCOPIC SURGICAL MESH
OXK
Mesh, Surgical, Collagen, Large Abdominal Wall Defects
23d
Cleared
Apr 17, 2013
VS3
GCJ
Laparoscope, General & Plastic Surgery
159d
Cleared
Apr 17, 2013
PLASMATRODE SALINE SAFE TUR ELECTRODE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
224d
Cleared
Apr 15, 2013
YOULASER CO2 LASER
GEX
Powered Laser Surgical Instrument
146d
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