The following data is part of a premarket notification filed by Covidien with the FDA for Eea Circular Stapler With Tri-staple Technology.
| Device ID | K221771 |
| 510k Number | K221771 |
| Device Name: | EEA Circular Stapler With Tri-Staple Technology |
| Classification | Staple, Implantable |
| Applicant | Covidien Rooms 501, 502, 601, 602, No. 3 Building No. 2388 Chen Hang Road Min Hang District, Shanghai, CN 201114 |
| Contact | Leo Chan |
| Correspondent | Leo Chen Covidien Rooms 501, 502, 601, 602, No.3 Building No.2388 Chen Hang Road Shanghai, CN |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-21 |
| Decision Date | 2022-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521593098 | K221771 | 000 |
| 20884521593081 | K221771 | 000 |
| 20884521592992 | K221771 | 000 |
| 20884521592985 | K221771 | 000 |