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 | K192330 |
| 510k Number | K192330 |
| 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 | Frank Gianelli 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 | 2019-08-27 |
| Decision Date | 2020-01-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521593173 | K192330 | 000 |
| 20884521593159 | K192330 | 000 |
| 20884521593135 | K192330 | 000 |
| 20884521593074 | K192330 | 000 |
| 20884521593050 | K192330 | 000 |
| 20884521593036 | K192330 | 000 |