Model 5151
FDA 510(k) K944821 · Richard Wolf Medical Instruments Corp.
510(k) numberK944821
Submission
- Device name
- Model 5151
- Applicant
- Richard Wolf Medical Instruments Corp.
Vernon Hills, IL, US - Received
- September 29, 1994
- Decision date
- November 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| 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 Model 5151 cleared by the FDA?
Model 5151 (K944821) received a 510(k) decision of Substantially Equivalent on November 14, 1994, 46 days after the submission was received.
What is the product code of K944821?
The FDA product code is GCT – Light Source, Endoscope, Xenon Arc, a Class II (moderate risk) device regulated under 21 CFR 876.1500.