FST · Class II · 21 CFR 878.4580

FDA Product Code FST: Light, Surgical, Fiberoptic

Leading manufacturers include Advanced Surgical Products, Inc., Cuda Products Co. and STERIS Corporation.

45
Total
45
Cleared
79d
Avg days
1977
Since

FDA 510(k) Cleared Light, Surgical, Fiberoptic Devices (Product Code FST)

45 devices
1–24 of 45
Cleared Jun 30, 2020
TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
K200874
Innovasis, Inc.
General & Plastic Surgery · 90d
Cleared Dec 15, 2014
ENDO-CORD
K141330
Enroxtech, Inc.
General & Plastic Surgery · 208d
Cleared Nov 01, 2012
LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999
K122637
Stryker Spine
General & Plastic Surgery · 64d
Cleared Feb 10, 2012
EIGR SURGICAL ILLUMINATION SYSTEM
K113697
Invuity, Inc.
General & Plastic Surgery · 56d
Cleared Jan 12, 2012
CABLECAP
K113330
Sensormed
General & Plastic Surgery · 59d
Cleared Sep 24, 2010
ISOLED AC-POWERED LED HEADLIGHT SYSTEM
K102266
Isolux, LLC
General & Plastic Surgery · 45d
Cleared Sep 14, 2010
CABLECAP MODEL: WLF, STZ, ACM
K101496
Sensormed
General & Plastic Surgery · 105d
Cleared Jun 22, 2010
21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS
K100388
Medical Illumination International, Inc.
General & Plastic Surgery · 126d
Cleared Mar 17, 2010
HARMONY VLED SURGICAL LIGHTNING SYSTEM
K100395
STERIS Corporation
General & Plastic Surgery · 29d
Cleared Jan 28, 2010
CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST
K093386
Bfw, Inc.
General & Plastic Surgery · 90d
Cleared Apr 22, 2009
INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
K090070
Invuity, Inc.
General & Plastic Surgery · 100d
Cleared Feb 23, 2009
RETRACTOR LITE
K083710
Thomas Surgical Instruments, Inc.
General & Plastic Surgery · 70d
Cleared Feb 18, 2009
AXXION LIGHT GUIDE
K082992
Spinal Elements, Inc.
General & Plastic Surgery · 134d
Cleared Jun 25, 2008
LITE WAND II
K080962
Thompson Surgical Instruments, Inc.
General & Plastic Surgery · 82d
Cleared Feb 22, 2008
ZIMMER MIS LIGHT
K080367
Zimmer Spine, Inc.
General & Plastic Surgery · 10d
Cleared Jun 14, 2007
PROXENON 350, MODEL 902XX
K071218
Welch Allyn, Inc.
General & Plastic Surgery · 43d
Cleared Sep 15, 2006
SURGICAL HEADLIGHT
K061690
Gulf Medical Fiberoptics
General & Plastic Surgery · 92d
Cleared Jan 13, 2006
LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES
K053227
Medical Illumination International, Inc.
General & Plastic Surgery · 57d
Cleared Aug 15, 2005
MELIDE FIBEROPTIC LIGHT
K051786
Designs For Vision, Inc.
General & Plastic Surgery · 45d
Cleared Oct 26, 2004
NUVASIVE MAXCESS LIGHT GUIDE
K042034
Nuvasive, Inc.
General & Plastic Surgery · 89d
Cleared Jan 29, 2001
STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT
K003577
STERIS Corporation
General & Plastic Surgery · 70d
Cleared Mar 21, 2000
MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE
K000728
Medtronic Xomed
General & Plastic Surgery · 15d
Cleared Jul 08, 1999
ISOLUX SURGICAL HEADLIGHT
K991572
Isolux America
General & Plastic Surgery · 64d
Cleared Mar 18, 1998
UFR FIBEROPTIC CABLE
K972225
Universal Fiberoptic Repair, Inc.
General & Plastic Surgery · 278d

About Product Code FST - Regulatory Context