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
14005 General & Plastic Surgery devices
Cleared
Jan 08, 2002
VIABAHN ENDOPROSTHESIS
JCT
Prosthesis, Tracheal, Expandable
64d
Cleared
Jan 08, 2002
L-25 ABSORBABLE SURIGCAL SUTURE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
63d
Cleared
Dec 27, 2001
FOTONA DUALIS, FOTONA DUALIS PLUS
GEX
Powered Laser Surgical Instrument
189d
Cleared
Dec 21, 2001
MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
GEX
Powered Laser Surgical Instrument
88d
Cleared
Dec 19, 2001
AUTO SUTURE SURGICAL STAPLES
GDW
Staple, Implantable
28d
Cleared
Dec 13, 2001
SOPRO 67D OPERATING ROOM CAMERA
GCJ
Laparoscope, General & Plastic Surgery
87d
Cleared
Dec 13, 2001
AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
FTD
Lamp, Surgical
76d
Cleared
Dec 13, 2001
INDIGO OPTIMA LASER SYSTEM
GEX
Powered Laser Surgical Instrument
52d
Cleared
Dec 10, 2001
SOCRATES ROBOTIC TELEMONITORING SYSTEM
NEQ
Device, Telemedicine, Robotic
25d
Cleared
Dec 06, 2001
REPROCESSED SOFT TISSUE ABLATORS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
115d
Cleared
Dec 06, 2001
PALOMAR SLP 1000
GEX
Powered Laser Surgical Instrument
87d
Cleared
Dec 06, 2001
MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
29d
Cleared
Dec 03, 2001
MENTOR CONTOUR PROFILE TISSUE EXPANDER
LCJ
Tissue Expander And Accessories
201d
Cleared
Dec 03, 2001
MACROPORE SURGIWRAP (TS)
FTL
Mesh, Surgical, Polymeric
158d
Cleared
Dec 03, 2001
APPLIED ACCESS SEAL
GCJ
Laparoscope, General & Plastic Surgery
90d
Cleared
Dec 03, 2001
MICROMARK II TISSUE MARKER,MODEL C1535
NEU
Marker, Radiographic, Implantable
49d
Cleared
Nov 27, 2001
RUSCH POLYFLEX STENT KIT
NYT
Prosthesis, Tracheal, Expandable, Polymeric
57d
Cleared
Nov 19, 2001
DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE
GEX
Powered Laser Surgical Instrument
202d
Cleared
Nov 19, 2001
CYNOSURE PHOTOGENICA VL
GEX
Powered Laser Surgical Instrument
90d
Cleared
Nov 16, 2001
CYNOSURE PHOTOGENICA ER
GEX
Powered Laser Surgical Instrument
88d
Cleared
Nov 16, 2001
INTUITIVE SURGICAL BIPOLAR FORCEPS
NAY
System, Surgical, Computer Controlled Instrument
85d
Cleared
Nov 16, 2001
MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE
NEW
Suture, Surgical, Absorbable, Polydioxanone
46d
Cleared
Nov 15, 2001
ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND
GEI
Electrosurgical, Cutting & Coagulation & Accessories
28d
Cleared
Nov 14, 2001
SYMPHONY GRAFT DELIVERY SYSTEM (GDS)
GEY
Motor, Surgical Instrument, Ac-powered
90d
Cleared
Nov 14, 2001
TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX
GCJ
Laparoscope, General & Plastic Surgery
89d
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