The following data is part of a premarket notification filed by Covidien Llc with the FDA for Tri-staple 2.0 Intelligent Cartridge.
| Device ID | K163098 |
| 510k Number | K163098 |
| Device Name: | Tri-Staple 2.0 Intelligent Cartridge |
| Classification | Staple, Implantable |
| Applicant | Covidien LLC 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Contact | Rebecca Brewer |
| Correspondent | Rebecca Brewer 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 | 2016-11-07 |
| Decision Date | 2016-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521543543 | K163098 | 000 |
| 20884521543536 | K163098 | 000 |
| 20884521543529 | K163098 | 000 |
| 20884521543512 | K163098 | 000 |