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
13870 General & Plastic Surgery devices
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 10, 2008
BOVIE IDS-400 ELECTROSURGICAL GENERATOR
GEI
Electrosurgical, Cutting & Coagulation & Accessories
260d
Cleared
Apr 09, 2008
PHARAON LIPO
GEX
Powered Laser Surgical Instrument
105d
Cleared
Apr 08, 2008
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
NUV
Massager, Vacuum, Light Induced Heating
63d
Cleared
Apr 07, 2008
SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER
GEX
Powered Laser Surgical Instrument
26d
Cleared
Apr 04, 2008
CRYOMINI
GEX
Powered Laser Surgical Instrument
18d
Cleared
Apr 04, 2008
TETRIX CREAM
FRO
Dressing, Wound, Drug
310d
Cleared
Apr 03, 2008
LTM-T SURGICAL MESH
FTL
Mesh, Surgical, Polymeric
52d
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
Apr 02, 2008
BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
34d
Cleared
Apr 02, 2008
ONCOBIONIC SYSTEM
OAB
Low Energy Direct Current Thermal Ablation System
50d
Cleared
Mar 31, 2008
GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP
NEU
Marker, Radiographic, Implantable
19d
Cleared
Mar 31, 2008
ARTHROCARE ORTHOWAND SURGICAL DEVICE
GEI
Electrosurgical, Cutting & Coagulation & Accessories
27d
Cleared
Mar 27, 2008
HABIB HEXABLATE 10
GEI
Electrosurgical, Cutting & Coagulation & Accessories
14d
Cleared
Mar 27, 2008
PORTRAIT PSR, MODEL 745915
GEI
Electrosurgical, Cutting & Coagulation & Accessories
143d
Cleared
Mar 26, 2008
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542
GEX
Powered Laser Surgical Instrument
72d
Cleared
Mar 26, 2008
MODIFICATION TO PALOMAR LUX1540 HANDPIECE
GEX
Powered Laser Surgical Instrument
97d
Cleared
Mar 25, 2008
E-VAC
GEI
Electrosurgical, Cutting & Coagulation & Accessories
106d
Cleared
Mar 21, 2008
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
NEW
Suture, Surgical, Absorbable, Polydioxanone
11d
Cleared
Mar 21, 2008
VIRTUAL PORTS ENDOCLEAR SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
73d
Cleared
Mar 21, 2008
SURGISIS BIODESIGN TISSUE GRAFT
FTM
Mesh, Surgical
109d
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
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