FDA Product Code
FDA Product Code HBI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4580
510(k) Clearances — 28 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K223183 | Light-Guide Cables | Olympus Winter & Ibe GmbH | 2023-01-13 | Traditional | PDF ↗ |
| K163185 | OptiLux LED Illuminator | Isolux, LLC | 2016-11-21 | Traditional | PDF ↗ |
| K141781 | KOGENT SPETZLER LIGHTED SUCTION TUBES | Katalyst Surgical, LLC | 2015-04-09 | Traditional | PDF ↗ |
| K111342 | LIGHT GUIDE CABLE | Schott North America | 2011-11-25 | Traditional | PDF ↗ |
| K052979 | 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE | Isolux, LLC | 2005-10-31 | Traditional | PDF ↗ |
| K021931 | ENDOSCOPIC FIBEROPTIC CABLE | Gulf Medical Fiberoptics | 2002-09-06 | Traditional | PDF ↗ |
| K991208 | ENDOSCOPIC FIBEROPTIC CABLE | Isolux America | 1999-06-23 | Traditional | PDF ↗ |
| K983277 | LIGHTSOURCE OR ILLUMINATOR MODEL I-100 | Cuda Products Co. | 1998-12-16 | Traditional | PDF ↗ |
| K933593 | LUMINOUS 150 FIBEROPTIC ILLUMINATOR | Progressive Dynamics, Inc. | 1993-10-28 | Traditional | PDF ↗ |
| K922837 | S1500 XENON LIGHT SOURCE | Endomedix | 1992-11-03 | Traditional | PDF ↗ |
| K922462 | NEXTEC FIBEROPTIC CABLES | Nextec Corp. | 1992-09-21 | Traditional | PDF ↗ |
| K921866 | LUMINOUS 250 FIBEROPTIC ILLUMINATOR | Progressive Dynamics, Inc. | 1992-07-08 | Traditional | PDF ↗ |
| K920167 | NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KEL | Nextec Corp. | 1992-03-23 | Traditional | PDF ↗ |
| K904616 | STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATOR | Storz Instrument Co. | 1991-04-19 | Traditional | PDF ↗ |
| K904609 | XENON LIGHT SOURCE | Medical Dynamics, Inc. | 1990-12-18 | Traditional | PDF ↗ |
| K904681 | VLS 5300 300W XENON LIGHT SOURCE | Vistek Corp. | 1990-12-18 | Traditional | PDF ↗ |
| K901108 | FIBERLUME | Burton | 1990-03-28 | Traditional | PDF ↗ |
| K896549 | STORZ FIBEROPTIC ENDO-ILLUMINATORS | Storz Instrument Co. | 1990-02-15 | Traditional | PDF ↗ |
| K890398 | RYAN-STYLE DIRECTED INFUSION MANIPULATOR | Advanced Surgical Products, Inc. | 1989-02-17 | Traditional | PDF ↗ |
| K883856 | FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE | Advanced Surgical Products, Inc. | 1988-09-29 | Traditional | PDF ↗ |
| K883857 | FIBEROPTIC WIRE PICK LIGHTPIPE | Advanced Surgical Products, Inc. | 1988-09-29 | Traditional | PDF ↗ |
| K883858 | FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE | Advanced Surgical Products, Inc. | 1988-09-29 | Traditional | PDF ↗ |
| K883201 | VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS | Vital Metrics, Inc. | 1988-09-26 | Traditional | PDF ↗ |
| K882956 | VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION | Vital Metrics, Inc. | 1988-08-03 | Traditional | PDF ↗ |
| K854587 | STORZ MVS DISPOSABLE FIBEROPTIC LIGHTPIPE | Storz Instrument Co. | 1986-02-04 | Traditional | PDF ↗ |
| K853948 | MINNESOTA SCIENTIFIC, INC. OMNI-BEAM | Minnesota Scientific, Inc. | 1985-10-16 | Traditional | PDF ↗ |
| K810300 | FIBER OPTIC ADAPTERS#60-0893 | Aspen Laboratories, Inc. | 1981-02-27 | Traditional | PDF ↗ |
| K810299 | FIBER OPTIC ADAPTERS#60-0891 | Aspen Laboratories, Inc. | 1981-02-27 | Traditional | PDF ↗ |
Product code HBI · Class II · General, Plastic Surgery. Data: openFDA.