Vygon Neo-Sump
FDA 510(k) K974806 · Vygon Corp.
510(k) numberK974806
Submission
- Device name
- Vygon Neo-Sump
- Applicant
- Vygon Corp.
West Cadwell, NJ, US - Received
- December 23, 1997
- Decision date
- March 23, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KNT – Tubes, Gastrointestinal (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Vygon Neo-Sump cleared by the FDA?
Vygon Neo-Sump (K974806) received a 510(k) decision of Substantially Equivalent on March 23, 1998, 90 days after the submission was received.
What is the product code of K974806?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.