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
18327
Total
18282
Cleared
139d
Avg (2y)
1976
Since
14209 General & Plastic Surgery devices
Cleared
Apr 29, 1992
HALOCATH LASER CATHETERS
GEX
Powered Laser Surgical Instrument
61d
Cleared
Apr 28, 1992
PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH
KGX
Tape And Bandage, Adhesive
153d
Cleared
Apr 21, 1992
ZARA SILICONE BLOCK
MIB
Elastomer, Silicone Block
236d
Cleared
Apr 21, 1992
DEROYAL HYDROGEL DRESSING
NAE
Dressing, Wound, Hydrogel Without Drug And/or Biologic
158d
Cleared
Apr 21, 1992
PERCUGUIDE LESION MARKING
GDF
Guide, Needle, Surgical
75d
Cleared
Apr 16, 1992
GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB
KDD
Kit, Surgical Instrument, Disposable
72d
Cleared
Apr 15, 1992
ORION
GEX
Powered Laser Surgical Instrument
457d
Cleared
Apr 15, 1992
GLEESON CLOT-BUSTER
GCI
Laryngoscope, Endoscope
93d
Cleared
Apr 10, 1992
ND:YAG SURGICAL LASER
GEX
Powered Laser Surgical Instrument
88d
Cleared
Apr 10, 1992
SCULPTURED ENDOSTAT
GEX
Powered Laser Surgical Instrument
60d
Cleared
Apr 07, 1992
PRODIGY ND:YAG SURGICAL LASER SYSTEM
GEX
Powered Laser Surgical Instrument
172d
Cleared
Apr 06, 1992
LAP TISSUE COLLECTION BAG
GCJ
Laparoscope, General & Plastic Surgery
133d
Cleared
Apr 02, 1992
LAPAROSTAT(TM)
HAM
Apparatus, Electrosurgical
252d
Cleared
Apr 02, 1992
KTP/YAG AND KTP/YAG PLUS
GEX
Powered Laser Surgical Instrument
176d
Cleared
Apr 02, 1992
MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM
GEX
Powered Laser Surgical Instrument
141d
Cleared
Apr 02, 1992
EXCEL MODEL XLT-TWO HOLMIUM:YAG LASER SYSTEM
GEX
Powered Laser Surgical Instrument
139d
Cleared
Apr 02, 1992
ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE
GEA
Cannula, Surgical, General & Plastic Surgery
86d
Cleared
Apr 02, 1992
GENESIS ELECTROSURGICAL UNIT
GEI
Electrosurgical, Cutting & Coagulation & Accessories
79d
Cleared
Apr 02, 1992
ZEISS MULTIYAG LASER
GEX
Powered Laser Surgical Instrument
57d
Cleared
Apr 02, 1992
LATERALASE
GEX
Powered Laser Surgical Instrument
50d
Cleared
Apr 02, 1992
SIDE FIRING FIBERS
GEX
Powered Laser Surgical Instrument
50d
Cleared
Mar 27, 1992
CO2 LASER AND WAVEGUIDE DELIVERY SYSTEMS FOR THOR.
GEX
Powered Laser Surgical Instrument
105d
Cleared
Mar 27, 1992
UNISTIK
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
50d
Cleared
Mar 26, 1992
DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC
GCY
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
107d
Cleared
Mar 23, 1992
LM15(TM), CATALOG NUMBER - 523821
GCJ
Laparoscope, General & Plastic Surgery
157d
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