The following data is part of a premarket notification filed by Covidien with the FDA for Endo Gia Reinforced Reload With Tri-staple Technology.
| Device ID | K133938 |
| 510k Number | K133938 |
| Device Name: | ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY |
| Classification | Staple, Implantable |
| Applicant | COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Contact | Jose Marquez |
| Correspondent | Jose Marquez COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-23 |
| Decision Date | 2014-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521191010 | K133938 | 000 |
| 20884521191003 | K133938 | 000 |
| 20884521190990 | K133938 | 000 |
| 20884521190884 | K133938 | 000 |