Tablet Application
FDA 510(k) K203566 · Smith & Nephew
510(k) numberK203566
Submission
- Device name
- Tablet Application
- Applicant
- Smith & Nephew
Andover, MA, US - Received
- December 7, 2020
- Decision date
- May 13, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODA – Endoscopic Central Control Unit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.
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Questions and answers
When was Tablet Application cleared by the FDA?
Tablet Application (K203566) received a 510(k) decision of Substantially Equivalent on May 13, 2021, 157 days after the submission was received.
What is the product code of K203566?
The FDA product code is ODA – Endoscopic Central Control Unit, a Class II (moderate risk) device regulated under 21 CFR 876.1500.