Endoscopic Light Source, Model XL300/L5
FDA 510(k) K021717 · World of Medicine Lemke GmbH
510(k) numberK021717
Submission
- Device name
- Endoscopic Light Source, Model XL300/L5
- Applicant
- World of Medicine Lemke GmbH
Cambridge, MA, US - Received
- May 23, 2002
- Decision date
- August 20, 2002
- 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
Other 510(k)s with product code GCT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K992540 | Xenon Light Source Pes 1GCT · Traditional | Laser Optik Systeme GmbH & Co. KG | 09/14/1999SE |
More from Laser Optik Systeme GmbH & Co. KG
| 510(k) | Device | Decision |
|---|---|---|
| K024251 | SightfixGCJ · Traditional | 03/18/2003SE |
| K023468 | Endoscopic Light Source XL180/L3GCT · Traditional | 01/14/2003SE |
| K021456 | ER150/M2GCJ · Traditional | 08/01/2002SE |
| K020889 | Endoscopic Light Source XL202/L3GCT · Traditional | 06/05/2002SE |
| K020336 | Endoscopic Camera MC404/C3GCJ · Traditional | 03/14/2002SE |
| K014158 | Endoscopic Camera TC804/C4GCJ · Traditional | 03/14/2002SE |
Questions and answers
When was Endoscopic Light Source, Model XL300/L5 cleared by the FDA?
Endoscopic Light Source, Model XL300/L5 (K021717) received a 510(k) decision of Substantially Equivalent on August 20, 2002, 89 days after the submission was received.
What is the product code of K021717?
The FDA product code is GCT – Light Source, Endoscope, Xenon Arc, a Class II (moderate risk) device regulated under 21 CFR 876.1500.