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
7638 General & Plastic Surgery devices
Cleared
Dec 16, 2013
HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE
LFL
Instrument, Ultrasonic Surgical
126d
Cleared
Dec 13, 2013
BARD VENTRALEX HERNIA PATCH
FTL
Mesh, Surgical, Polymeric
129d
Cleared
Dec 11, 2013
ERBE ESU MODEL VIO DV WITH ACCESSORIES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
55d
Cleared
Dec 06, 2013
PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
36d
Cleared
Dec 05, 2013
TFCC FAST-FIX KIT
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
153d
Cleared
Dec 03, 2013
HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY
LFL
Instrument, Ultrasonic Surgical
36d
Cleared
Dec 03, 2013
HEM-O-LOK LIGATING CLIP
FZP
Clip, Implantable
47d
Cleared
Dec 02, 2013
OPTIFIX ABSORBABLE FIXATION SYSTEM
GDW
Staple, Implantable
144d
Cleared
Nov 27, 2013
HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS
FZP
Clip, Implantable
93d
Cleared
Oct 30, 2013
SMITH & NEPHEW ULTRATAPE
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
93d
Cleared
Oct 24, 2013
HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE
LFL
Instrument, Ultrasonic Surgical
73d
Cleared
Oct 24, 2013
(QUANTA SYSTEM) SURGICAL LASER FIBERS
GEX
Powered Laser Surgical Instrument
155d
Cleared
Oct 23, 2013
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
GDW
Staple, Implantable
75d
Cleared
Oct 23, 2013
RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE
OMP
Negative Pressure Wound Therapy Powered Suction Pump
78d
Cleared
Oct 18, 2013
ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK
GDW
Staple, Implantable
133d
Cleared
Oct 17, 2013
HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE
LFL
Instrument, Ultrasonic Surgical
57d
Cleared
Oct 16, 2013
MEDLINE SUCTION COAGULATOR
GEI
Electrosurgical, Cutting & Coagulation & Accessories
387d
Cleared
Oct 08, 2013
WECK EFX ENDO FASCIAL CLOSURE SYSTEM
OCW
Endoscopic Tissue Approximation Device
70d
Cleared
Oct 08, 2013
PRONTOSAN WOUND GEL X
FRO
Dressing, Wound, Drug
194d
Cleared
Oct 04, 2013
THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
GAD
Retractor
42d
Cleared
Oct 03, 2013
DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST
GEI
Electrosurgical, Cutting & Coagulation & Accessories
79d
Cleared
Oct 03, 2013
ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW,
GEI
Electrosurgical, Cutting & Coagulation & Accessories
136d
Cleared
Sep 13, 2013
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
OWN
Confocal Optical Imaging
259d
Cleared
Sep 06, 2013
GORE SEAMGUARD REINFORCEMENT
OXC
Mesh, Surgical, Absorbable, Staple Line Reinforcement
92d
Cleared
Aug 29, 2013
REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
87d
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