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
13747 General & Plastic Surgery devices
Cleared
Jul 30, 2014
SUCTION LIPOPLASTY ACCESSORIES
QPB
System, Suction, Lipoplasty For Removal
366d
Cleared
Jul 29, 2014
SKINTACT
GEI
Electrosurgical, Cutting & Coagulation & Accessories
152d
Cleared
Jul 28, 2014
STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
168d
Cleared
Jul 28, 2014
OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
224d
Cleared
Jul 25, 2014
SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL)
GEX
Powered Laser Surgical Instrument
17d
Cleared
Jul 25, 2014
LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS
GDW
Staple, Implantable
63d
Cleared
Jul 25, 2014
ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS
NAY
System, Surgical, Computer Controlled Instrument
143d
Cleared
Jul 25, 2014
CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)
OWN
Confocal Optical Imaging
255d
Cleared
Jul 23, 2014
ARTHROSCOPIC ENERGY SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
139d
Cleared
Jul 23, 2014
SIS HERNIA GRAFT
FTM
Mesh, Surgical
268d
Cleared
Jul 22, 2014
SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
39d
Cleared
Jul 22, 2014
BIO-CONNEKT WOUND MATRIX
KGN
Wound Dressing With Animal-derived Material(s)
148d
Cleared
Jul 22, 2014
PICOSURE WORKSTATION
GEX
Powered Laser Surgical Instrument
263d
Cleared
Jul 18, 2014
POLYSYN SURGICAL SUTURE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
31d
Cleared
Jul 18, 2014
ALMA DIODE TABLETOP LASER
GEX
Powered Laser Surgical Instrument
197d
Cleared
Jul 17, 2014
D2 HEMOSTANTIC DRESSING
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
113d
Cleared
Jul 17, 2014
TATTOOSTAR EFFECT COMBO
GEX
Powered Laser Surgical Instrument
395d
Cleared
Jul 15, 2014
LINSCAN 808, LINSCAN 980
GEX
Powered Laser Surgical Instrument
82d
Cleared
Jul 15, 2014
AESCULAP OPTILENE NONABSORBABLE SUTURE
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
207d
Cleared
Jul 11, 2014
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
29d
Cleared
Jul 11, 2014
ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
137d
Cleared
Jul 11, 2014
FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE
GEX
Powered Laser Surgical Instrument
308d
Cleared
Jul 10, 2014
3D EPTFE
FWP
Prosthesis, Chin, Internal
79d
Cleared
Jul 10, 2014
THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
118d
Cleared
Jul 10, 2014
ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS
GCJ
Laparoscope, General & Plastic Surgery
176d
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