Vital-Vue Illumination, Suction & Irrigation Sys
FDA 510(k) K883201 · Vital Metrics, Inc.
510(k) numberK883201
Submission
- Device name
- Vital-Vue Illumination, Suction & Irrigation Sys
- Applicant
- Vital Metrics, Inc.
San Diego, CA, US - Received
- July 28, 1988
- Decision date
- September 26, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K141781 | Kogent Spetzler Lighted Suction TubesHBI · Traditional | Katalyst Surgical, LLC | 04/09/2015SE |
| 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 |
| K922837 | S1500 Xenon Light SourceHBI · Traditional | Endomedix | 11/03/1992SE |
More from Endomedix
| 510(k) | Device | Decision |
|---|---|---|
| K882956 | Vital-Vue Illumination, Suction and IrrigationHBI · Traditional | 08/03/1988SE |
| K844973 | Irriga Suc Illum Isis 710 & 7100 Series · Traditional | 03/18/1985SE |
| K843442 | Urinary Drainage Container 2013 withFFG · Traditional | 01/03/1985SE |
| K843441 | Urinary Drainage Container 2012-WITHFFG · Traditional | 01/03/1985SE |
| K840917 | Urinary Monitoring Sys 240KNX · Traditional | 05/01/1984SE |
| K834448 | Urinary Drainage ContainerKNX · Traditional | 02/10/1984SE |
| K832526 | Urotrack PlusKNX · Traditional | 09/19/1983SE |
| K813641 | Vital Metrics Urine Monitoring SystemFFG · Traditional | 03/01/1982SE |
Questions and answers
When was Vital-Vue Illumination, Suction & Irrigation Sys cleared by the FDA?
Vital-Vue Illumination, Suction & Irrigation Sys (K883201) received a 510(k) decision of Substantially Equivalent on September 26, 1988, 60 days after the submission was received.
What is the product code of K883201?
The FDA product code is HBI – Illuminator, Fiberoptic, Surgical Field, a Class II (moderate risk) device regulated under 21 CFR 878.4580.