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
18256
Total
18211
Cleared
136d
Avg (2y)
1976
Since
7645 General & Plastic Surgery devices
Cleared
May 06, 2008
HEPATOSTAT SET
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
146d
Cleared
May 05, 2008
SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER
GEX
Powered Laser Surgical Instrument
10d
Cleared
May 05, 2008
ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE
FZP
Clip, Implantable
24d
Cleared
Apr 25, 2008
PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
FRO
Dressing, Wound, Drug
324d
Cleared
Apr 23, 2008
ELIPO
GEX
Powered Laser Surgical Instrument
114d
Cleared
Apr 17, 2008
COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
GEX
Powered Laser Surgical Instrument
51d
Cleared
Apr 16, 2008
C-QUR EDGE MESH V-PATCH
FTL
Mesh, Surgical, Polymeric
36d
Cleared
Apr 16, 2008
C-QUR LITE MESH V-PATCH
FTL
Mesh, Surgical, Polymeric
36d
Cleared
Apr 16, 2008
CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
KDD
Kit, Surgical Instrument, Disposable
198d
Cleared
Apr 10, 2008
WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08
FTM
Mesh, Surgical
147d
Cleared
Apr 03, 2008
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
GEX
Powered Laser Surgical Instrument
108d
Cleared
Apr 02, 2008
AESCULAP ENDOSCOPIC CLIP SYTEM
FZP
Clip, Implantable
16d
Cleared
Apr 02, 2008
ERBE VIO ESU, MODEL VIO 200 S
GEI
Electrosurgical, Cutting & Coagulation & Accessories
20d
Cleared
Mar 31, 2008
ARTHROCARE ORTHOWAND SURGICAL DEVICE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
27d
Cleared
Mar 26, 2008
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542
GEX
Powered Laser Surgical Instrument
72d
Cleared
Mar 20, 2008
ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01
GEI
Electrosurgical, Cutting & Coagulation & Accessories
27d
Cleared
Mar 19, 2008
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER
NAY
System, Surgical, Computer Controlled Instrument
44d
Cleared
Mar 19, 2008
SINUS SPACER
KAM
Cannula, Sinus
161d
Cleared
Mar 13, 2008
PREVADH MESH
FTL
Mesh, Surgical, Polymeric
113d
Cleared
Mar 11, 2008
RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
KAM
Cannula, Sinus
134d
Cleared
Mar 06, 2008
MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
43d
Cleared
Feb 28, 2008
AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE
GEX
Powered Laser Surgical Instrument
57d
Cleared
Feb 28, 2008
Q-PLUS T
GEX
Powered Laser Surgical Instrument
72d
Cleared
Feb 25, 2008
ETHICON ENDO SURGERY ARTICULATING NEEDLE KNIFE, MODEL 2504
GEI
Electrosurgical, Cutting & Coagulation & Accessories
119d
Cleared
Feb 22, 2008
ZIMMER MIS LIGHT
FST
Light, Surgical, Fiberoptic
10d
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