The Keymed Hi-Light 250 Light Source
FDA 510(k) K864801 · Keymed, Inc.
510(k) numberK864801
Submission
- Device name
- The Keymed Hi-Light 250 Light Source
- Applicant
- Keymed, Inc.
Essex Ss2 5qh England, GB - Received
- December 9, 1986
- Decision date
- December 24, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCT – Light Source, Endoscope, Xenon Arc
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K093125 | Alphaxenon Light 180 W and 300 WGCT · Abbreviated | Gimmi GmbH | 01/27/2010SE |
| K082925 | XENON-100 SCB Light Source, Model 20132620GCT · Traditional | KARL STORZ Endoscopy-America, Inc. | 12/18/2008SE |
| K070376 | Conmed Linvatec 300W Xenon Light SourceGCT · Traditional | Conmed Linvatec | 08/20/2007SE |
| K040949 | Viaduct Miniscope and AccessoriesGCT · Traditional | Acueity, Inc. | 05/07/2004SE |
| K022490 | Ksea Medi PackGCT · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/29/2003SE |
| K031994 | Linvatec 300W Xenon Light SourceGCT · Traditional | Linvatec Corp. | 08/21/2003SE |
| K023468 | Endoscopic Light Source XL180/L3GCT · Traditional | World of Medicine Lemke GmbH | 01/14/2003SE |
| K021717 | Endoscopic Light Source, Model XL300/L5GCT · Traditional | World of Medicine Lemke GmbH | 08/20/2002SE |
| K020889 | Endoscopic Light Source XL202/L3GCT · Traditional | World of Medicine Lemke GmbH | 06/05/2002SE |
| K013880 | Daylite Xenon Light SourcesGCT · Traditional | Designs For Vision, Inc. | 12/07/2001SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K100803 | Olympus Flushing Pump Ofp Model: OFP-1FEQ · Special | 04/22/2010SE |
| K921179 | Olympus-Keymed Disinfectant Fume Extractor DFE-20FEB · Traditional | 03/29/1993SE |
| K881004 | Olympus-Keymed Endoscopic CO2 Regulator, Model EcrFCX · Traditional | 05/12/1988SE |
| K861821 | Keymed Fiberscope Auto DisinfectorNVE · Traditional | 02/12/1987SE |
| K862000 | Keymed Flexible Esophageal DilatorsKNQ · Traditional | 08/12/1986SE |
| K860528 | The Keymed Fiberscope Sterilization CaseKCT · Traditional | 07/15/1986SE |
| K861147 | UCS-2, Ultrasonic Cleaning SolutionFLG · Traditional | 06/23/1986SE |
| K860704 | The Keymed Sigmoidoscope Disinfection StandNZA · Traditional | 06/17/1986SE |
| K851149 | Key Med Transendoscopic Vascular Detector TVD-1JAF · Traditional | 11/26/1985SE |
| K854304 | Keymed Office CouchFPO · Traditional | 11/12/1985SE |
Questions and answers
When was The Keymed Hi-Light 250 Light Source cleared by the FDA?
The Keymed Hi-Light 250 Light Source (K864801) received a 510(k) decision of Substantially Equivalent on December 24, 1986, 15 days after the submission was received.
What is the product code of K864801?
The FDA product code is GCT – Light Source, Endoscope, Xenon Arc, a Class II (moderate risk) device regulated under 21 CFR 876.1500.