The following data is part of a premarket notification filed by Covidien with the FDA for Signia Circular Adapters (for Use With Signia Staplers), Tri-staple 2.0 Circular Reloads (for Use With Signia Circular Adapters).
| Device ID | K182475 |
| 510k Number | K182475 |
| Device Name: | Signia Circular Adapters (for Use With Signia Staplers), Tri-Staple 2.0 Circular Reloads (for Use With Signia Circular Adapters) |
| Classification | Staple, Implantable |
| Applicant | Covidien 60 Middletown Avenue North Haven, CT 06473 |
| Contact | Katherine Y. Choi |
| Correspondent | Katherine Y. Choi Covidien 60 Middletown Avenue North Haven, CT 06473 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-10 |
| Decision Date | 2019-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521703800 | K182475 | 000 |
| 20884521703787 | K182475 | 000 |
| 20884521703763 | K182475 | 000 |
| 20884521703749 | K182475 | 000 |
| 20884521703725 | K182475 | 000 |
| 20884521703718 | K182475 | 000 |
| 10884521703704 | K182475 | 000 |
| 10884521703698 | K182475 | 000 |
| 10884521703681 | K182475 | 000 |