GCT — Light Source, Endoscope, Xenon Arc Class II
FDA product code GCT covers "Light Source, Endoscope, Xenon Arc", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GCT
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K093125 | gimmi | ALPHAXENON LIGHT 180 W AND 300 W | January 27, 2010 |
| K082925 | karl storz endoscopy-america | XENON-100 SCB LIGHT SOURCE, MODEL 20132620 | December 18, 2008 |
| K070376 | conmed linvatec | CONMED LINVATEC 300W XENON LIGHT SOURCE | August 20, 2007 |
| K040949 | acueity | VIADUCT MINISCOPE AND ACCESSORIES | May 7, 2004 |
| K022490 | karl storz endoscopy-america | KSEA MEDI PACK | September 29, 2003 |
| K031994 | linvatec | LINVATEC 300W XENON LIGHT SOURCE | August 21, 2003 |
| K023468 | world of medicine lemke | ENDOSCOPIC LIGHT SOURCE XL180/L3 | January 14, 2003 |
| K021717 | world of medicine lemke | ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 | August 20, 2002 |
| K020889 | world of medicine lemke | ENDOSCOPIC LIGHT SOURCE XL202/L3 | June 5, 2002 |
| K013880 | designs for vision | DAYLITE XENON LIGHT SOURCES | December 7, 2001 |
| K992050 | walter lorenz surgical | LUMENON XENON LIGHT SOURCE | September 14, 1999 |
| K992540 | laser optik systeme gmbh and co. kg | XENON LIGHT SOURCE PES 1 | September 14, 1999 |
| K983628 | richard wolf medical instruments | XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011 | December 11, 1998 |
| K982962 | contec medical vision | XENON LIGHT SOURCE, MODELS LS6180, LS6035 | September 23, 1998 |
| K981804 | contec medical vision | XENON LIGHT SOURCE MODEL LS6000 | July 24, 1998 |
| K980281 | welch allyn | WELCH ALLYN XENON 300 LIGHT SOURCE | February 27, 1998 |
| K971057 | cogent light technologies | COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM | March 28, 1997 |
| K963227 | products for medicine | WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 | October 23, 1996 |
| K963044 | corin usa | ENDOBEAM | September 20, 1996 |
| K962365 | dsp worldwide | XENON LIGHTSOURCE | July 18, 1996 |