Linvatec 300W Xenon Light Source
FDA 510(k) K031994 · Linvatec Corp.
510(k) numberK031994
Submission
- Device name
- Linvatec 300W Xenon Light Source
- Applicant
- Linvatec Corp.
Largo, FL, US - Received
- June 27, 2003
- Decision date
- August 21, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| 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 |
| 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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Questions and answers
When was Linvatec 300W Xenon Light Source cleared by the FDA?
Linvatec 300W Xenon Light Source (K031994) received a 510(k) decision of Substantially Equivalent on August 21, 2003, 55 days after the submission was received.
What is the product code of K031994?
The FDA product code is GCT – Light Source, Endoscope, Xenon Arc, a Class II (moderate risk) device regulated under 21 CFR 876.1500.