Panels › General, Plastic Surgery › Product code HBI · Class 2
Illuminator, Fiberoptic, Surgical Field
Regulation 878.4580
0510(k)s in 12 months (28 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Advanced Surgical Products, Inc. | 4 | 0 |
| Storz Instrument Co. | 3 | 0 |
| Aspen Laboratories, Inc. | 2 | 0 |
| Isolux, LLC | 2 | 0 |
| Nextec Corp. | 2 | 0 |
| Progressive Dynamics, Inc. | 2 | 0 |
| Vital Metrics, Inc. | 2 | 0 |
| Burton | 1 | 0 |
| Cuda Products Co. | 1 | 0 |
| Endomedix | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 13, 2023 | K223183 | Light-Guide Cables Olympus Winter & Ibe GmbH, DE | HBI |
| Nov 21, 2016 | K163185 | OptiLux LED Illuminator Isolux, LLC | HBI |
| Apr 9, 2015 | K141781 | KOGENT SPETZLER LIGHTED SUCTION TUBES Katalyst Surgical, LLC | HBI |
| Nov 25, 2011 | K111342 | LIGHT GUIDE CABLE Schott North America | HBI |
| Oct 31, 2005 | K052979 | 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE Isolux, LLC | HBI |
| Sep 6, 2002 | K021931 | ENDOSCOPIC FIBEROPTIC CABLE Gulf Medical Fiberoptics | HBI |
| Jun 23, 1999 | K991208 | ENDOSCOPIC FIBEROPTIC CABLE Isolux America | HBI |
| Dec 16, 1998 | K983277 | LIGHTSOURCE OR ILLUMINATOR MODEL I-100 Cuda Products Co. | HBI |
| Oct 28, 1993 | K933593 | LUMINOUS 150 FIBEROPTIC ILLUMINATOR Progressive Dynamics, Inc. | HBI |
| Nov 3, 1992 | K922837 | S1500 XENON LIGHT SOURCE Endomedix | HBI |
| Sep 21, 1992 | K922462 | NEXTEC FIBEROPTIC CABLES Nextec Corp. | HBI |
| Jul 8, 1992 | K921866 | LUMINOUS 250 FIBEROPTIC ILLUMINATOR Progressive Dynamics, Inc. | HBI |
| Mar 23, 1992 | K920167 | NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KEL Nextec Corp. | HBI |
| Apr 19, 1991 | K904616 | STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATOR Storz Instrument Co. | HBI |
| Dec 18, 1990 | K904681 | VLS 5300 300W XENON LIGHT SOURCE Vistek Corp. | HBI |
| Dec 18, 1990 | K904609 | XENON LIGHT SOURCE Medical Dynamics, Inc. | HBI |
| Mar 28, 1990 | K901108 | FIBERLUME Burton | HBI |
| Feb 15, 1990 | K896549 | STORZ FIBEROPTIC ENDO-ILLUMINATORS Storz Instrument Co. | HBI |
| Feb 17, 1989 | K890398 | RYAN-STYLE DIRECTED INFUSION MANIPULATOR Advanced Surgical Products, Inc. | HBI |
| Sep 29, 1988 | K883858 | FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE Advanced Surgical Products, Inc. | HBI |
| Sep 29, 1988 | K883857 | FIBEROPTIC WIRE PICK LIGHTPIPE Advanced Surgical Products, Inc. | HBI |
| Sep 29, 1988 | K883856 | FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE Advanced Surgical Products, Inc. | HBI |
| Sep 26, 1988 | K883201 | VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS Vital Metrics, Inc. | HBI |
| Aug 3, 1988 | K882956 | VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION Vital Metrics, Inc. | HBI |
| Feb 4, 1986 | K854587 | STORZ MVS DISPOSABLE FIBEROPTIC LIGHTPIPE Storz Instrument Co. | HBI |
| Oct 16, 1985 | K853948 | MINNESOTA SCIENTIFIC, INC. OMNI-BEAM Minnesota Scientific, Inc. | HBI |
| Feb 27, 1981 | K810300 | FIBER OPTIC ADAPTERS#60-0893 Aspen Laboratories, Inc. | HBI |
| Feb 27, 1981 | K810299 | FIBER OPTIC ADAPTERS#60-0891 Aspen Laboratories, Inc. | HBI |
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