S1500 Xenon Light Source
FDA 510(k) K922837 · Endomedix
510(k) numberK922837
Submission
- Device name
- S1500 Xenon Light Source
- Applicant
- Endomedix
Irvine, CA, US - Received
- June 12, 1992
- Decision date
- November 3, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HBI – Illuminator, Fiberoptic, Surgical Field
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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| K163185 | OptiLux LED IlluminatorHBI · Traditional | Isolux, LLC | 11/21/2016SE |
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| K111342 | Light Guide CableHBI · Traditional | Schott North America | 11/25/2011SE |
| K052979 | 1125 XSB Xenon Fiber-Optic Light SourceHBI · Traditional | Isolux, LLC | 10/31/2005SE |
| K021931 | Endoscopic Fiberoptic CableHBI · Traditional | Gulf Medical Fiberoptics | 09/06/2002SE |
| K991208 | Endoscopic Fiberoptic CableHBI · Traditional | Isolux America | 06/23/1999SE |
| K983277 | Lightsource or Illuminator Model I-100HBI · Traditional | Cuda Products Co. | 12/16/1998SE |
| K933593 | Luminous 150 Fiberoptic IlluminatorHBI · Traditional | Progressive Dynamics, Inc. | 10/28/1993SE |
| K922462 | Nextec Fiberoptic CablesHBI · Traditional | Nextec Corp. | 09/21/1992SE |
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|---|---|---|
| K934170 | Endomedix Y-AdapterOCX · Traditional | 01/11/1994SE |
| K934623 | Endoscopic Video System and Endoscopic Video CameraFET · Traditional | 12/02/1993SE |
| K930499 | Grasping Forceps Flexible Stone DislodgerOCZ · Traditional | 08/16/1993SE |
| K930349 | Stone Retrieval BasketFFL · Traditional | 06/09/1993SE |
| K926004 | Endoscope and AccossoriesFGB · Traditional | 02/10/1993SE |
| K922082 | Laparoscopic IntroducerGCJ · Traditional | 08/03/1992SE |
Questions and answers
When was S1500 Xenon Light Source cleared by the FDA?
S1500 Xenon Light Source (K922837) received a 510(k) decision of Substantially Equivalent on November 3, 1992, 144 days after the submission was received.
What is the product code of K922837?
The FDA product code is HBI – Illuminator, Fiberoptic, Surgical Field, a Class II (moderate risk) device regulated under 21 CFR 878.4580.