Panels › General, Plastic Surgery › Product code FST · Class 2
Light, Surgical, Fiberoptic
Regulation 878.4580
0510(k)s in 12 months (45 all time)
0recalls in 12 months (12 all time)
10recalls that name a 510(k)
Top companies in FST
| Company | 510(k)s | Recalls |
|---|---|---|
| Integra LifeSciences Corp. | 0 | 9 |
| Advanced Surgical Products, Inc. | 5 | 0 |
| Cuda Products Co. | 3 | 0 |
| STERIS Corporation | 2 | 1 |
| Gulf Medical Fiberoptics | 1 | 1 |
| Invuity, Inc. | 2 | 0 |
| Medical Illumination International, Inc. | 2 | 0 |
| Sensormed | 2 | 0 |
| Bfw, Inc. | 1 | 0 |
| Cogent Light Technologies, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 30, 2020 | K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End Innovasis, Inc. | FST |
| Dec 15, 2014 | K141330 | ENDO-CORD Enroxtech, Inc. | FST |
| Nov 1, 2012 | K122637 | LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 Stryker Spine | FST |
| Feb 10, 2012 | K113697 | EIGR SURGICAL ILLUMINATION SYSTEM Invuity, Inc. | FST |
| Jan 12, 2012 | K113330 | CABLECAP Sensormed | FST |
| Sep 24, 2010 | K102266 | ISOLED AC-POWERED LED HEADLIGHT SYSTEM Isolux, LLC | FST |
| Sep 14, 2010 | K101496 | CABLECAP MODEL: WLF, STZ, ACM Sensormed | FST |
| Jun 22, 2010 | K100388 | 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS Medical Illumination International, Inc. | FST |
| Mar 17, 2010 | K100395 | HARMONY VLED SURGICAL LIGHTNING SYSTEM STERIS Corporation | FST |
| Jan 28, 2010 | K093386 | CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST Bfw, Inc. | FST |
| Apr 22, 2009 | K090070 | INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM Invuity, Inc. | FST |
| Feb 23, 2009 | K083710 | RETRACTOR LITE Thomas Surgical Instruments, Inc. | FST |
| Feb 18, 2009 | K082992 | AXXION LIGHT GUIDE Spinal Elements, Inc. | FST |
| Jun 25, 2008 | K080962 | LITE WAND II Thompson Surgical Instruments, Inc. | FST |
| Feb 22, 2008 | K080367 | ZIMMER MIS LIGHT Zimmer Spine, Inc. | FST |
| Jun 14, 2007 | K071218 | PROXENON 350, MODEL 902XX Welch Allyn, Inc. | FST |
| Sep 15, 2006 | K061690 | SURGICAL HEADLIGHT Gulf Medical Fiberoptics | FST |
| Jan 13, 2006 | K053227 | LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES Medical Illumination International, Inc. | FST |
| Aug 15, 2005 | K051786 | MELIDE FIBEROPTIC LIGHT Designs For Vision, Inc. | FST |
| Oct 26, 2004 | K042034 | NUVASIVE MAXCESS LIGHT GUIDE Nuvasive, Inc. | FST |
| Jan 29, 2001 | K003577 | STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT STERIS Corporation | FST |
| Mar 21, 2000 | K000728 | MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE Medtronic Xomed | FST |
| Jul 8, 1999 | K991572 | ISOLUX SURGICAL HEADLIGHT Isolux America | FST |
| Mar 18, 1998 | K972225 | UFR FIBEROPTIC CABLE Universal Fiberoptic Repair, Inc. | FST |
| Jan 31, 1996 | K955510 | X6000D SILENT SUN LIGHT SOURCE Products For Medicine | FST |
| Mar 10, 1994 | K936048 | LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) Cogent Light Technologies, Inc. | FST |
| Feb 9, 1994 | K931546 | END-IRRIGATING ENDOILLUMINATOR Infinitech, Inc. | FST |
| Sep 2, 1992 | K922820 | WOODBINE XT350, XENON ARC LIGHT SOURCE Woodbine Ptical Corp. | FST |
| Aug 7, 1992 | K922544 | MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE Kirschner Medical Corp. | FST |
| May 13, 1992 | K921646 | NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON Nextec Corp. | FST |
| Jan 23, 1992 | K915274 | METAL HALIDE LIGHT SOURCE MODEL LM 250 Pentax Precision Instrument Corp. | FST |
| Jun 27, 1991 | K912252 | INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT Fiberoptic Medical Products, Inc. | FST |
| Aug 29, 1990 | K903800 | FIBER OPTIC LIGHT CABLE Orlux Engineering and Instrumentation, CA | FST |
| Jun 18, 1990 | K901491 | CUDA SURGICAL LIGHT Cuda Products Co. | FST |
| Apr 23, 1990 | K901035 | FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE Cuda Products Co. | FST |
| Jul 24, 1989 | K893828 | ML-800 AUTOELECTRONIC LIGHT SOURCE M.P. Video, Inc. | FST |
| Jun 22, 1989 | K893491 | MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300 Cuda Products Co. | FST |
| Mar 14, 1988 | K875007 | PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA. Advanced Surgical Products, Inc. | FST |
| Mar 14, 1988 | K875006 | PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK Advanced Surgical Products, Inc. | FST |
| Mar 14, 1988 | K875005 | PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA. Advanced Surgical Products, Inc. | FST |
| Mar 14, 1988 | K875004 | PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK Advanced Surgical Products, Inc. | FST |
| Mar 7, 1988 | K875195 | OPHTHALMIC LIGHT PIPE PICK Trek Medical Products, Inc. | FST |
| Apr 3, 1987 | K870942 | MVS FIBEROPTIC LIGHTPIPE Advanced Surgical Products, Inc. | FST |
| Nov 19, 1986 | K864380 | LUTEX HEADLIGHT SYSTEMS Luxtec Corp. | FST |
| Jan 5, 1977 | K761142 | HEADLIGHTS W/ FILTER-OPTICO CABLES Pilling Co. | FST |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.