The following data is part of a premarket notification filed by Covidien with the FDA for Kangaroo Gastrostomy Feeding Tube With Enfit Y-port.
| Device ID | K180622 |
| 510k Number | K180622 |
| Device Name: | Kangaroo Gastrostomy Feeding Tube With ENFit Y-Port |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Covidien 15 Hampshire Street Mansfield, MA 02048 |
| Contact | Alexis Erazo |
| Correspondent | Alexis Erazo Covidien 15 Hampshire Street Mansfield, MA 02048 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-09 |
| Decision Date | 2018-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521661629 | K180622 | 000 |