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
13836 General & Plastic Surgery devices
Cleared
Apr 22, 2009
PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)
FWP
Prosthesis, Chin, Internal
13d
Cleared
Apr 22, 2009
INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
FST
Light, Surgical, Fiberoptic
100d
Cleared
Apr 21, 2009
MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
FZP
Clip, Implantable
22d
Cleared
Apr 17, 2009
VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM
MVR
Device, Anastomotic, Microvascular
32d
Cleared
Apr 17, 2009
ISKRA MEDICAL GREEN IRF PRESTIGE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
134d
Cleared
Apr 16, 2009
PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS
GCJ
Laparoscope, General & Plastic Surgery
38d
Cleared
Apr 16, 2009
SILVER WOUND PAD
FRO
Dressing, Wound, Drug
127d
Cleared
Apr 14, 2009
CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C
GEX
Powered Laser Surgical Instrument
36d
Cleared
Apr 14, 2009
BLUESHINE GOLD SERIES
GEX
Powered Laser Surgical Instrument
67d
Cleared
Apr 14, 2009
ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM
GEX
Powered Laser Surgical Instrument
111d
Cleared
Apr 10, 2009
AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS
GDW
Staple, Implantable
135d
Cleared
Apr 08, 2009
QUIKCLOT INTEVENTIONAL, MODEL P/N 182
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
30d
Cleared
Apr 08, 2009
INCISIVE FAMILY OF INPULSE ND:YAG LASERS
GEX
Powered Laser Surgical Instrument
159d
Cleared
Apr 08, 2009
PROWICK
FRO
Dressing, Wound, Drug
182d
Cleared
Apr 02, 2009
NEOSALUS CREAM
FRO
Dressing, Wound, Drug
29d
Cleared
Apr 02, 2009
ATMOS S041 WOUND
OMP
Negative Pressure Wound Therapy Powered Suction Pump
71d
Cleared
Apr 02, 2009
ASAP WOUND DRESSING GEL
FRO
Dressing, Wound, Drug
231d
Cleared
Apr 01, 2009
BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
9d
Cleared
Apr 01, 2009
SOPRO 184 CAMERA
GCJ
Laparoscope, General & Plastic Surgery
190d
Cleared
Mar 31, 2009
CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
85d
Cleared
Mar 27, 2009
COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY
GEX
Powered Laser Surgical Instrument
37d
Cleared
Mar 27, 2009
SYNTHASOME X-REPAIR
FTL
Mesh, Surgical, Polymeric
137d
Cleared
Mar 27, 2009
GORE BIO-A FISTULA PLUG
FTL
Mesh, Surgical, Polymeric
142d
Cleared
Mar 27, 2009
HYLATOPIC EMOLLIENT FOAM
MGQ
Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
169d
Cleared
Mar 26, 2009
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
195d
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