The following data is part of a premarket notification filed by Covidien (dba Medtronic) with the FDA for Kangaroo Feeding Tube With Iris Technology.
| Device ID | K163002 |
| 510k Number | K163002 |
| Device Name: | Kangaroo Feeding Tube With IRIS Technology |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Covidien (dba Medtronic) 15 Hampshire St Mansfield, MA 02048 |
| Contact | Alexis Erazo |
| Correspondent | Alexis Erazo Covidien (dba Medtronic) 15 Hampshire St 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 | 2016-10-28 |
| Decision Date | 2017-05-16 |
| Summary: | summary |