McLean-Ring Enteral Feeding Tube Set
FDA 510(k) K190084 · Cook Incorporated
510(k) numberK190084
Submission
- Device name
- McLean-Ring Enteral Feeding Tube Set
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- January 17, 2019
- Decision date
- October 11, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 McLean-Ring Enteral Feeding Tube Set cleared by the FDA?
McLean-Ring Enteral Feeding Tube Set (K190084) received a 510(k) decision of Substantially Equivalent on October 11, 2019, 267 days after the submission was received.
What is the product code of K190084?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.