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
Feb 22, 2011
ALACER SURGICAL SCAFFOLD
FTL
Mesh, Surgical, Polymeric
90d
Cleared
Feb 22, 2011
MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY
FRO
Dressing, Wound, Drug
239d
Cleared
Feb 16, 2011
CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT
GEI
Electrosurgical, Cutting & Coagulation & Accessories
62d
Cleared
Feb 15, 2011
ATRIUM CENTRILFX MESH
FTL
Mesh, Surgical, Polymeric
32d
Cleared
Feb 15, 2011
SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER
GEX
Powered Laser Surgical Instrument
54d
Cleared
Feb 15, 2011
ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR
MTJ
Wax, Bone
144d
Cleared
Feb 10, 2011
SPPHINE PLUS STM 3W DIODE LASER
GEX
Powered Laser Surgical Instrument
30d
Cleared
Feb 10, 2011
REUSABLE LINEAR STAPLER HANDLE
GDW
Staple, Implantable
34d
Cleared
Feb 10, 2011
PSORIA-LIGHT
FTC
Light, Ultraviolet, Dermatological
70d
Cleared
Feb 09, 2011
CRYONIZE TM
GEH
Unit, Cryosurgical, Accessories
91d
Cleared
Feb 07, 2011
MEDEOR MATRIX
FTM
Mesh, Surgical
42d
Cleared
Feb 04, 2011
VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
46d
Cleared
Feb 04, 2011
5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319
NAY
System, Surgical, Computer Controlled Instrument
227d
Cleared
Feb 04, 2011
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100
GCJ
Laparoscope, General & Plastic Surgery
291d
Cleared
Jan 31, 2011
DEKA SYNCHRO FT
GEX
Powered Laser Surgical Instrument
84d
Cleared
Jan 26, 2011
ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
OTJ
Laparoscopic Single Port Access Device
23d
Cleared
Jan 21, 2011
MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM
NUV
Massager, Vacuum, Light Induced Heating
273d
Cleared
Jan 21, 2011
LIPOCONTROL
ORK
Laser Assisted Lipolysis
672d
Cleared
Jan 20, 2011
QUANTA SYSTEM DUOLITE
GEX
Powered Laser Surgical Instrument
49d
Cleared
Jan 20, 2011
LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
323d
Cleared
Jan 14, 2011
ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES
GEX
Powered Laser Surgical Instrument
46d
Cleared
Jan 14, 2011
ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ
GEI
Electrosurgical, Cutting & Coagulation & Accessories
94d
Cleared
Jan 12, 2011
SMARTXIDE 50 HS/MS
GEX
Powered Laser Surgical Instrument
188d
Cleared
Jan 11, 2011
PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER
GDW
Staple, Implantable
46d
Cleared
Jan 05, 2011
LTF-Y0009
GCJ
Laparoscope, General & Plastic Surgery
135d
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