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
13832 General & Plastic Surgery devices
Cleared
Apr 06, 2011
HAIRMAX LASERCOMB
OAP
Laser, Comb, Hair
140d
Cleared
Apr 05, 2011
CUTERA GENESISPLUS LASER SYSTEM
PDZ
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
116d
Cleared
Apr 04, 2011
SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM
QPB
System, Suction, Lipoplasty For Removal
66d
Cleared
Apr 04, 2011
THE ARTAS SYSTEM FROM RESTORATION ROBOTICS
ONA
Computer Assisted Hair Harvesting System
133d
Cleared
Apr 01, 2011
VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM
FTL
Mesh, Surgical, Polymeric
9d
Cleared
Apr 01, 2011
HYLATOPICPLUS CREAM
FRO
Dressing, Wound, Drug
16d
Cleared
Mar 29, 2011
FLEXIVA TRACTIP
GEX
Powered Laser Surgical Instrument
18d
Cleared
Mar 28, 2011
ACCUTRAC
GEX
Powered Laser Surgical Instrument
17d
Cleared
Mar 25, 2011
LIGAMAX 5
FZP
Clip, Implantable
11d
Cleared
Mar 25, 2011
ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
GDW
Staple, Implantable
43d
Cleared
Mar 24, 2011
MANUKATEX
FRO
Dressing, Wound, Drug
77d
Cleared
Mar 23, 2011
CELSTAT
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
141d
Cleared
Mar 23, 2011
VENTRALEX ST HERNIA PATCH
FTL
Mesh, Surgical, Polymeric
257d
Cleared
Mar 23, 2011
VENTRIO ST HERNIA PATCH
FTL
Mesh, Surgical, Polymeric
257d
Cleared
Mar 18, 2011
JOULE MULTI-PLATFORM SYSTEM
GEX
Powered Laser Surgical Instrument
252d
Cleared
Mar 17, 2011
PRIMUS AESTHETIC PLATFORM
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
91d
Cleared
Mar 16, 2011
PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL
GEI
Electrosurgical, Cutting & Coagulation & Accessories
120d
Cleared
Mar 14, 2011
SILVER ANTIMICROBIAL WOUND GEL
FRO
Dressing, Wound, Drug
25d
Cleared
Mar 04, 2011
PARIETEX PROGRIP
FTL
Mesh, Surgical, Polymeric
77d
Cleared
Mar 02, 2011
SURGISURE TISSUE REMOVAL SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
69d
Cleared
Feb 28, 2011
CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
80d
Cleared
Feb 24, 2011
RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
GEX
Powered Laser Surgical Instrument
44d
Cleared
Feb 24, 2011
VACPLUS SUCTION UNIT
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
85d
Cleared
Feb 24, 2011
SILS PORT
GCJ
Laparoscope, General & Plastic Surgery
113d
Cleared
Feb 22, 2011
ML24000 UVA-1 PHOTOTHERAPY UNIT
FTC
Light, Ultraviolet, Dermatological
64d
Looking for a specific general & plastic surgery device? Search by device name, K-number or manufacturer.
Search all General & Plastic Surgery 510(k) devices