Endolight LED 1.1 Endolightled 1.2
FDA 510(k) K121724 · Richard Wolf Medical Instruments Corp.
510(k) numberK121724
Submission
- Device name
- Endolight LED 1.1 Endolightled 1.2
- Applicant
- Richard Wolf Medical Instruments Corp.
Vernon Hills, IL, US - Received
- June 12, 2012
- Decision date
- September 20, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FCW – Light Source, Fiberoptic, Routine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FCW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131226 | Novaprobe LED Light SourceFCW · Traditional | Novaprobe Incorporated | 07/24/2014SE |
| K123956 | Power LED 175FCW · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/25/2013SE |
| K123359 | OVS1 Video SystemFCW · Traditional | Olive Medical Corp. | 12/19/2012SE |
| K093792 | LED Light SourceFCW · Traditional | Sunoptic Technologies, LLC | 03/18/2010SE |
| K091968 | Karl Storz LED Nova 100 Cold Light Fountain, Models 2016020, 20161020CFCW · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/14/2009SE |
| K082813 | Stryker LED LightsourceFCW · Traditional | Stryker Corp. | 12/19/2008SE |
| K081477 | Luxtec MLX Light SourceFCW · Traditional | Integra Luxtec, Inc. | 06/18/2008SE |
| K032430 | Acueity Medical Light SourceFCW · Traditional | Acueity, Inc. | 09/05/2003SE |
| K012265 | Metal Halide Light Source, Models MV-9088-T, MV-9088FCW · Traditional | Circon Video | 10/17/2001SE |
| K000229 | Videolabs Medcam Proplus Video Camera and Integral Light SourceFCW · Traditional | Videolabs, Inc. | 03/21/2000SE |
More from Videolabs, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K231291 | Perforated BasketsKCT · Traditional | 06/03/2024SE |
| K230194 | HF Surgery Generator 400KHZGEI · Traditional | 03/22/2023SE |
| K212808 | Logic Hd camera head green, System greenFET · Traditional | 06/14/2022SE |
| K211332 | D Camera ControllerFET · Traditional | 10/01/2021SE |
| K203226 | Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O 10MM WL…GCM · Traditional | 05/14/2021SE |
| K201897 | Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525FGB · Traditional | 01/15/2021SE |
| K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller…FET · Traditional | 06/23/2020SE |
| K183188 | Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA…FGB · Traditional | 05/03/2019SE |
| K180583 | Logic 4K Camera Controller, Logic 4K Camera HeadFET · Traditional | 06/28/2018SE |
| K170377 | TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL…GEI · Traditional | 04/05/2017SE |
Questions and answers
When was Endolight LED 1.1 Endolightled 1.2 cleared by the FDA?
Endolight LED 1.1 Endolightled 1.2 (K121724) received a 510(k) decision of Substantially Equivalent on September 20, 2012, 100 days after the submission was received.
What is the product code of K121724?
The FDA product code is FCW – Light Source, Fiberoptic, Routine, a Class II (moderate risk) device regulated under 21 CFR 876.1500.