The following data is part of a premarket notification filed by Covidien with the FDA for Autosuture Eea Stapler / Circular Stapler With Dst Series Technology / Eea Autosuture Circular Stapler With Dst Series Technology / Dst Series Eea Stapler / Dst Eea.
| Device ID | K221003 |
| 510k Number | K221003 |
| Device Name: | Autosuture EEA Stapler / Circular Stapler With DST Series Technology / EEA Autosuture Circular Stapler With DST Series Technology / DST Series EEA Stapler / DST EEA |
| Classification | Staple, Implantable |
| Applicant | Covidien 60 Middletown Avenue North Haven, CT 06473 |
| Contact | Sanja Jahr |
| Correspondent | Sanja Jahr 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 | 2022-04-05 |
| Decision Date | 2022-09-30 |