The following data is part of a premarket notification filed by Covidien with the FDA for Gia Stapler With Tri-staple Technology.
| Device ID | K202701 |
| 510k Number | K202701 |
| Device Name: | GIA 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 Chen |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-16 |
| Decision Date | 2020-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521723570 | K202701 | 000 |
| 20884521723501 | K202701 | 000 |
| 20884521723495 | K202701 | 000 |
| 20884521723433 | K202701 | 000 |