The following data is part of a premarket notification filed by Covidien with the FDA for Gia Stapler With Tri-staple Technology.
| Device ID | K221006 |
| 510k Number | K221006 |
| Device Name: | GIA Stapler With Tri-Staple Technology |
| Classification | Staple, Implantable |
| Applicant | Covidien Room 501, 502, 601, 602 No.3 Building No.2388, Chen Hang Road Min Hang District, Shanghai, CN 201114 |
| Contact | Yanjun Jiao |
| Correspondent | Katherine 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 | 2022-04-05 |
| Decision Date | 2022-04-29 |