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
Jun 10, 2014
A.I.M. KNOTLESS MENISCAL REPAIR DEVICE
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
181d
Cleared
Jun 10, 2014
QUADROSTARPROGREEN, QUADROSTARPROYELLOW
GEX
Powered Laser Surgical Instrument
228d
Cleared
Jun 09, 2014
VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES
FSY
Light, Surgical, Ceiling Mounted
59d
Cleared
Jun 06, 2014
ATOVEN
GEX
Powered Laser Surgical Instrument
176d
Cleared
Jun 05, 2014
HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
107d
Cleared
Jun 05, 2014
ENDOWRIST VESSEL SEALER
NAY
System, Surgical, Computer Controlled Instrument
132d
Cleared
Jun 04, 2014
VTI SUCTION IRRIGATION SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
15d
Cleared
May 30, 2014
ULTRAPRO COMFORT PLUG
FTL
Mesh, Surgical, Polymeric
225d
Cleared
May 30, 2014
A-TONE IPL SYSTEM
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
353d
Cleared
May 30, 2014
DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
526d
Cleared
May 28, 2014
FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
GAQ
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
132d
Cleared
May 23, 2014
FMWAND HANDPIECE SE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
98d
Cleared
May 23, 2014
MINNIE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
198d
Cleared
May 23, 2014
NUTRA LIGHT BLUE
OLP
Over-the-counter Powered Light Based Laser For Acne
255d
Cleared
May 22, 2014
CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
234d
Cleared
May 21, 2014
GALAFLEX MESH
OOD
Surgical Film
78d
Cleared
May 20, 2014
GENERAL AND PLASTIC SURGERY
NEU
Marker, Radiographic, Implantable
48d
Cleared
May 20, 2014
ASAP OTC WOUND DRESSING GEL
FRO
Dressing, Wound, Drug
83d
Cleared
May 19, 2014
THUNDERBEAT
GEI
Electrosurgical, Cutting & Coagulation & Accessories
263d
Cleared
May 16, 2014
LUMENA FH HAIR REMOVAL SYSTEM
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
65d
Cleared
May 16, 2014
AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM
NRB
Wound Cleaner, Ultrasound
393d
Cleared
May 15, 2014
EXTRICARE
OMP
Negative Pressure Wound Therapy Powered Suction Pump
302d
Cleared
May 14, 2014
STOP U (PACKED BLACK USA)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
103d
Cleared
May 14, 2014
OMNIPORE CUSTOMIZED SURGICAL IMPLANTS
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
229d
Cleared
May 13, 2014
AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP
MPN
Tissue Adhesive For The Topical Approximation Of Skin
91d
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