ManoScan System
FDA 510(k) K151086 · Given Imaging , Ltd.
510(k) numberK151086
Submission
- Device name
- ManoScan System
- Applicant
- Given Imaging , Ltd.
Yoqneam, IL - Received
- April 22, 2015
- Decision date
- April 28, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFX – System, Gastrointestinal Motility (Electrical)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was ManoScan System cleared by the FDA?
ManoScan System (K151086) received a 510(k) decision of Substantially Equivalent on April 28, 2016, 372 days after the submission was received.
What is the product code of K151086?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.