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
7639 General & Plastic Surgery devices
Cleared
Feb 10, 2011
REUSABLE LINEAR STAPLER HANDLE
GDW
Staple, Implantable
34d
Cleared
Feb 04, 2011
5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319
NAY
System, Surgical, Computer Controlled Instrument
227d
Cleared
Feb 04, 2011
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100
GCJ
Laparoscope, General & Plastic Surgery
291d
Cleared
Jan 20, 2011
QUANTA SYSTEM DUOLITE
GEX
Powered Laser Surgical Instrument
49d
Cleared
Jan 14, 2011
ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ
GEI
Electrosurgical, Cutting & Coagulation & Accessories
94d
Cleared
Jan 05, 2011
LTF-Y0009
GCJ
Laparoscope, General & Plastic Surgery
135d
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 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 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 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 07, 2010
ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
GDW
Staple, Implantable
24d
Cleared
Sep 29, 2010
FAT CONCENTRATION SYSTEM
MUU
System, Suction, Lipoplasty
257d
Cleared
Sep 23, 2010
AFFIRM DO DIODE LASER
GEX
Powered Laser Surgical Instrument
107d
Cleared
Sep 17, 2010
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
FTL
Mesh, Surgical, Polymeric
182d
Cleared
Sep 15, 2010
COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
GDW
Staple, Implantable
34d
Cleared
Aug 11, 2010
HYBRID TROCAR SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
30d
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