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
14011 General & Plastic Surgery devices
Cleared
Apr 02, 2001
VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR
GEI
Electrosurgical, Cutting & Coagulation & Accessories
90d
Cleared
Mar 29, 2001
CYNOSURE PHOTOGENICA NEO-V
GEX
Powered Laser Surgical Instrument
90d
Cleared
Mar 26, 2001
SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER
GEX
Powered Laser Surgical Instrument
90d
Cleared
Mar 26, 2001
LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100
GEI
Electrosurgical, Cutting & Coagulation & Accessories
83d
Cleared
Mar 26, 2001
AMS FASCIAL-ANCHORING SYSTEM
NEH
Anchor, Fascial
55d
Cleared
Mar 22, 2001
ENDIUS BIPOLAR SHEATH
GEI
Electrosurgical, Cutting & Coagulation & Accessories
94d
Cleared
Mar 19, 2001
MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD
MDA
Elastomer, Silicone, For Scar Management
87d
Cleared
Mar 16, 2001
INDIGO LASEROPTIC TREATMENT SYSTEM
GEX
Powered Laser Surgical Instrument
85d
Cleared
Mar 16, 2001
INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001
GEX
Powered Laser Surgical Instrument
85d
Cleared
Mar 16, 2001
MRI SAFE INSTRUMENTS
GEA
Cannula, Surgical, General & Plastic Surgery
84d
Cleared
Mar 07, 2001
SLT DIFFUSER FIBER
GEX
Powered Laser Surgical Instrument
61d
Cleared
Mar 06, 2001
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
GEX
Powered Laser Surgical Instrument
90d
Cleared
Mar 02, 2001
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM
NAY
System, Surgical, Computer Controlled Instrument
204d
Cleared
Mar 01, 2001
PALOMAR SPALIGHT PULSED LIGHT SYSTEM
GEX
Powered Laser Surgical Instrument
73d
Cleared
Mar 01, 2001
CONTOUR PROFILE LASER
GEX
Powered Laser Surgical Instrument
29d
Cleared
Feb 28, 2001
ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP
GEI
Electrosurgical, Cutting & Coagulation & Accessories
14d
Cleared
Feb 22, 2001
VISULAS YAG II
GEX
Powered Laser Surgical Instrument
69d
Cleared
Feb 22, 2001
ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP
GCJ
Laparoscope, General & Plastic Surgery
51d
Cleared
Feb 21, 2001
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
FTL
Mesh, Surgical, Polymeric
28d
Cleared
Jan 29, 2001
STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT
FST
Light, Surgical, Fiberoptic
70d
Cleared
Jan 25, 2001
TWILITE, TWILITE WHITE
GEX
Powered Laser Surgical Instrument
86d
Cleared
Jan 25, 2001
PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM
GEX
Powered Laser Surgical Instrument
79d
Cleared
Jan 25, 2001
DENLASER, MODEL 800
GEX
Powered Laser Surgical Instrument
70d
Cleared
Jan 24, 2001
SOFRADIM PARIETEX SURGICAL MESHES
FTL
Mesh, Surgical, Polymeric
29d
Cleared
Jan 22, 2001
COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
FTL
Mesh, Surgical, Polymeric
90d
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