The following data is part of a premarket notification filed by Xeridiem Medical Devices with the FDA for Entuit Thrive Balloon Retention Gastrostomy Feeding Tube.
| Device ID | K130611 |
| 510k Number | K130611 |
| Device Name: | ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | XERIDIEM MEDICAL DEVICES 4700 S Overland Dr Tucson, AZ 85714 |
| Contact | Michelle Lott |
| Correspondent | Michelle Lott XERIDIEM MEDICAL DEVICES 4700 S Overland Dr Tucson, AZ 85714 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-07 |
| Decision Date | 2013-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827002447858 | K130611 | 000 |
| 10827002447810 | K130611 | 000 |
| 10827002447827 | K130611 | 000 |
| 10827002447834 | K130611 | 000 |
| 10827002447865 | K130611 | 000 |
| 00827002356146 | K130611 | 000 |
| 00827002356153 | K130611 | 000 |
| 00827002356160 | K130611 | 000 |
| 00827002356177 | K130611 | 000 |
| 00827002356184 | K130611 | 000 |
| 00827002356191 | K130611 | 000 |
| 00827002356207 | K130611 | 000 |
| 10827002447841 | K130611 | 000 |
| 10827002447803 | K130611 | 000 |