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
13762 General & Plastic Surgery devices
Cleared
Oct 25, 2013
MIRADRY SYSTEM
OUB
Instrument For Treatment Of Hyperhidrosis
184d
Cleared
Oct 25, 2013
BIPOLAR FORCEPS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
192d
Cleared
Oct 25, 2013
TRIA FAN SYSTEM
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
245d
Cleared
Oct 25, 2013
COVAMESH
FTL
Mesh, Surgical, Polymeric
247d
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 23, 2013
MARIGEN WOUND DRESSING
KGN
Wound Dressing With Animal-derived Material(s)
85d
Cleared
Oct 23, 2013
DYNAMESH -CICAT
FTL
Mesh, Surgical, Polymeric
148d
Cleared
Oct 22, 2013
GEM FLOW COUPLER DEVICE AND SYSTEM
MVR
Device, Anastomotic, Microvascular
49d
Cleared
Oct 18, 2013
MULTIFUNCTIONAL SERIES
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
116d
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 11, 2013
BASIC AND DOMINANT FLEX SUCTION PUMPS
BTA
Pump, Portable, Aspiration (manual Or Powered)
267d
Cleared
Oct 08, 2013
WECK EFX ENDO FASCIAL CLOSURE SYSTEM
OCW
Endoscopic Tissue Approximation Device
70d
Cleared
Oct 08, 2013
UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
83d
Cleared
Oct 08, 2013
INMODE WMBODY DEVICE
NUV
Massager, Vacuum, Light Induced Heating
148d
Cleared
Oct 08, 2013
PRONTOSAN WOUND GEL X
FRO
Dressing, Wound, Drug
194d
Cleared
Oct 08, 2013
MEDDUSA BIPOLAR SYSTEM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
265d
Cleared
Oct 07, 2013
ESTECH COBRA(R) GENESIS BIPOLAR CLAMP
GEI
Electrosurgical, Cutting & Coagulation & Accessories
11d
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
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