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
14087 General & Plastic Surgery devices
Cleared
Nov 24, 1997
SOFTFORM FACIAL IMPLANT
FTL
Mesh, Surgical, Polymeric
73d
Cleared
Nov 21, 1997
DOW CORNING SILASTIC ELASTOMER Q7-4750
MIB
Elastomer, Silicone Block
88d
Cleared
Nov 21, 1997
ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
88d
Cleared
Nov 21, 1997
OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT
GCJ
Laparoscope, General & Plastic Surgery
85d
Cleared
Nov 20, 1997
MARKMAN TEMPLATE SYSTEM
GAH
Stylet, Surgical, General & Plastic Surgery
297d
Cleared
Nov 19, 1997
SKAR-KARE
MDA
Elastomer, Silicone, For Scar Management
78d
Cleared
Nov 14, 1997
SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER
FZW
Expander, Surgical, Skin Graft
162d
Cleared
Nov 13, 1997
PIVOTAL SCISSOR
GEI
Electrosurgical, Cutting & Coagulation & Accessories
133d
Cleared
Nov 13, 1997
ENDOPATH ULTRA-RETRACTOR/ ENDOPATH VESSEL DISSECTOR
GCJ
Laparoscope, General & Plastic Surgery
84d
Cleared
Nov 13, 1997
HOOK ELECTRODE, NEEDLE ELECTRODE, COAGULATION BUTTON ELECTRODE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
69d
Cleared
Nov 13, 1997
CYNOSURE PHOTOGENICA ER LASER
GEX
Powered Laser Surgical Instrument
59d
Cleared
Nov 13, 1997
DURALASTIC ANATOMICAL NASAL IMPLANTS
FZE
Prosthesis, Nose, Internal
55d
Cleared
Nov 13, 1997
SILICONE CARVING BLOCK
MIB
Elastomer, Silicone Block
44d
Cleared
Nov 12, 1997
3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES
MGP
Dressing, Wound And Burn, Occlusive
90d
Cleared
Nov 07, 1997
O2 BOOT
KPJ
Chamber, Oxygen, Topical, Extremity
196d
Cleared
Nov 07, 1997
KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING
GCJ
Laparoscope, General & Plastic Surgery
81d
Cleared
Nov 07, 1997
UNCOATED ELECTROSURGICAL ELECTRODE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
63d
Cleared
Nov 07, 1997
IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT
LZK
Implant, Malar
52d
Cleared
Nov 07, 1997
DURALASTIC ANATOMICAL CHIN IMPLANTS
FWP
Prosthesis, Chin, Internal
49d
Cleared
Nov 06, 1997
ENDOSCOPES W/PERMANENT AND REMOVABLE EYEPIECE, PANOVIEW PLUS TELESCOPE W/PLUG-ON CONNECTOR
GCJ
Laparoscope, General & Plastic Surgery
90d
Cleared
Nov 05, 1997
ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
75d
Cleared
Nov 04, 1997
VENTRAL WALL DEFECT REDUCTION SILO
FTL
Mesh, Surgical, Polymeric
78d
Cleared
Nov 03, 1997
PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIES
GEX
Powered Laser Surgical Instrument
206d
Cleared
Oct 30, 1997
SONIQUE HAIR REMOVER
KCX
Epilator, High Frequency, Tweezer-type
66d
Cleared
Oct 30, 1997
FEMINIQUE SONIC HAIR REMOVER
KCX
Epilator, High Frequency, Tweezer-type
66d
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