Kogent Spetzler Lighted Suction Tubes
FDA 510(k) K141781 · Katalyst Surgical, LLC
510(k) numberK141781
Submission
- Device name
- Kogent Spetzler Lighted Suction Tubes
- Applicant
- Katalyst Surgical, LLC
Chesterfield, MO, US - Received
- July 2, 2014
- Decision date
- April 9, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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|---|---|---|---|
| K223183 | Light-Guide CablesHBI · Traditional | Olympus Winter & Ibe GmbH | 01/13/2023SE |
| K163185 | OptiLux LED IlluminatorHBI · Traditional | Isolux, LLC | 11/21/2016SE |
| 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 |
| K922462 | Nextec Fiberoptic CablesHBI · Traditional | Nextec Corp. | 09/21/1992SE |
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| K192963 | Kogent Torus Ultrasonic AspiratorLFL · Traditional | 06/19/2020SE |
| K163632 | Katalyst Cyclophotocoagulation ProbeLQJ · Traditional | 06/15/2017SE |
| K140362 | Katalyst Revolver Laser Probes, Katalyst Revolver Illuminated Laser Probes, Katalyst…HQF · Traditional | 09/15/2014SE |
| K123172 | Kogent Bipolar ForcepsGEI · Traditional | 12/21/2012SE |
| K121187 | Katalyst Laser Probes, Katalyst Illuminated Laser ProbesHQF · Traditional | 09/17/2012SE |
Questions and answers
When was Kogent Spetzler Lighted Suction Tubes cleared by the FDA?
Kogent Spetzler Lighted Suction Tubes (K141781) received a 510(k) decision of Substantially Equivalent on April 9, 2015, 281 days after the submission was received.
What is the product code of K141781?
The FDA product code is HBI – Illuminator, Fiberoptic, Surgical Field, a Class II (moderate risk) device regulated under 21 CFR 878.4580.