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 | K172361 |
| 510k Number | K172361 |
| 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 | Sarah Tang |
| Correspondent | Sarah Tang Covidien Rooms 501, 502, 601, 602 No.3 Building No.2388, Chen Hang Road Min Hang District, Shanghai, CN 201114 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-04 |
| Decision Date | 2018-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521593142 | K172361 | 000 |
| 20884521593067 | K172361 | 000 |
| 20884521593166 | K172361 | 000 |
| 20884521593043 | K172361 | 000 |
| 20884521593029 | K172361 | 000 |
| 20884521593159 | K172361 | 000 |