Barone Jejunostomy Catheter Set
FDA 510(k) K160567 · Cook Incorporated
510(k) numberK160567
Submission
- Device name
- Barone Jejunostomy Catheter Set
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- February 29, 2016
- Decision date
- May 18, 2017
- 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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| K190903 | Lawson Retrograde Nephrostomy Wire Puncture SetLJE · Traditional | 12/16/2019SE |
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Questions and answers
When was Barone Jejunostomy Catheter Set cleared by the FDA?
Barone Jejunostomy Catheter Set (K160567) received a 510(k) decision of Substantially Equivalent on May 18, 2017, 444 days after the submission was received.
What is the product code of K160567?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.