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 Mar 17, 2010
HARMONY VLED SURGICAL LIGHTNING SYSTEM
K100395
STERIS Corporation
General & Plastic Surgery · 29d
Cleared Feb 18, 2009
AXXION LIGHT GUIDE
K082992
Spinal Elements, Inc.
General & Plastic Surgery · 134d
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 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 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
Cleared Jan 31, 1996
X6000D SILENT SUN LIGHT SOURCE
K955510
Products For Medicine
General & Plastic Surgery · 58d
Cleared Aug 07, 1992
MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE
K922544
Kirschner Medical Corp.
General & Plastic Surgery · 70d
Cleared Jan 23, 1992
METAL HALIDE LIGHT SOURCE MODEL LM 250
K915274
Pentax Precision Instrument Corp.
General & Plastic Surgery · 59d
Cleared Jun 18, 1990
CUDA SURGICAL LIGHT
K901491
Cuda Products Co.
General & Plastic Surgery · 81d
Cleared Apr 23, 1990
FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE
K901035
Cuda Products Co.
General & Plastic Surgery · 48d
Cleared Jun 22, 1989
MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300
K893491
Cuda Products Co.
General & Plastic Surgery · 49d
Cleared Mar 14, 1988
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK
K875004
Advanced Surgical Products, Inc.
General & Plastic Surgery · 101d
Cleared Mar 14, 1988
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
K875005
Advanced Surgical Products, Inc.
General & Plastic Surgery · 101d
Cleared Mar 14, 1988
PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK
K875006
Advanced Surgical Products, Inc.
General & Plastic Surgery · 101d
Cleared Mar 14, 1988
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
K875007
Advanced Surgical Products, Inc.
General & Plastic Surgery · 101d
Cleared Apr 03, 1987
MVS FIBEROPTIC LIGHTPIPE
K870942
Advanced Surgical Products, Inc.
General & Plastic Surgery · 25d

About Product Code FST - Regulatory Context