D Camera Controller
FDA 510(k) K211332 · Richard Wolf Medical Instruments Corporation
510(k) numberK211332
Submission
- Device name
- D Camera Controller
- Applicant
- Richard Wolf Medical Instruments Corporation
Vernon Hills, IL, US - Received
- May 3, 2021
- Decision date
- October 1, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FET – Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
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Questions and answers
When was D Camera Controller cleared by the FDA?
D Camera Controller (K211332) received a 510(k) decision of Substantially Equivalent on October 1, 2021, 151 days after the submission was received.
What is the product code of K211332?
The FDA product code is FET – Endoscopic Video Imaging System/Component, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.