The following data is part of a premarket notification filed by Covidien Llc with the FDA for Endo Gia Radial Reload With Tri-staple Technology.
| Device ID | K132493 |
| 510k Number | K132493 |
| Device Name: | ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY |
| Classification | Staple, Implantable |
| Applicant | Covidien LLC 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Contact | Katherine Kassim |
| Correspondent | Katherine Kassim Covidien LLC 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-09 |
| Decision Date | 2013-10-23 |
| Summary: | summary |