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
Jan 03, 2011
TANDA MAX
ONE
Powered Light Based Non-laser Surgical Instrument
42d
Cleared
Dec 30, 2010
AXIOM FASCIAL CLOSURE SYSTEM
OCW
Endoscopic Tissue Approximation Device
38d
Cleared
Dec 29, 2010
SAPPHIRE ST PORTABLE DIODE LASER
GEX
Powered Laser Surgical Instrument
14d
Cleared
Dec 22, 2010
RESTORELLE POLYPROPYLENE MESH
FTL
Mesh, Surgical, Polymeric
16d
Cleared
Dec 16, 2010
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM
FTL
Mesh, Surgical, Polymeric
83d
Cleared
Dec 16, 2010
CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY
GEX
Powered Laser Surgical Instrument
84d
Cleared
Dec 15, 2010
ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT
GEX
Powered Laser Surgical Instrument
79d
Cleared
Dec 10, 2010
QUANTA CYBER TM 150W
GEX
Powered Laser Surgical Instrument
78d
Cleared
Dec 10, 2010
ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH
GEI
Electrosurgical, Cutting & Coagulation & Accessories
191d
Cleared
Dec 10, 2010
PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
FRO
Dressing, Wound, Drug
316d
Cleared
Dec 08, 2010
PRUITT CAROTID KIT
MJN
Catheter, Intravascular Occluding, Temporary
22d
Cleared
Dec 08, 2010
CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
64d
Cleared
Dec 02, 2010
SECRMARK BIOPSY SITE MARKING SYSTEM
NEU
Marker, Radiographic, Implantable
69d
Cleared
Nov 26, 2010
ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT
GEX
Powered Laser Surgical Instrument
308d
Cleared
Nov 24, 2010
CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
174d
Cleared
Nov 23, 2010
PATCHASSIST LARGE
ORQ
Mesh, Surgical, Deployer
19d
Cleared
Nov 23, 2010
CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
97d
Cleared
Nov 22, 2010
ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY
GDW
Staple, Implantable
18d
Cleared
Nov 22, 2010
LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N
GEX
Powered Laser Surgical Instrument
145d
Cleared
Nov 16, 2010
LAPAROSCOPIC DISSECTOR
GEI
Electrosurgical, Cutting & Coagulation & Accessories
11d
Cleared
Nov 10, 2010
V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
27d
Cleared
Nov 09, 2010
EMATRIX CO2
GEX
Powered Laser Surgical Instrument
182d
Cleared
Nov 05, 2010
PARIETEX PLUG AND PATCH
FTL
Mesh, Surgical, Polymeric
156d
Cleared
Nov 03, 2010
PRONTOSAN ANTIMICROBIAL WOUND GEL
FRO
Dressing, Wound, Drug
120d
Cleared
Oct 27, 2010
ENDOVASCULAR LAER VEIN SYSTEM KIT
GEX
Powered Laser Surgical Instrument
131d
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