510(k) K180622
K180622 is an FDA 510(k) premarket notification submitted by Covidien for the device "Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port". The FDA issued a decision of Substantially Equivalent on Oct 23, 2018. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Covidien has 224 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 23, 2018
- Date Received
- Mar 9, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
- 510(k)