The following data is part of a premarket notification filed by Covidien with the FDA for Gia Stapler With Tri-staple Technology.
| Device ID | K192720 |
| 510k Number | K192720 |
| 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, 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 | 2019-09-27 |
| Decision Date | 2020-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521723563 | K192720 | 000 |
| 20884521723532 | K192720 | 000 |
| 20884521723525 | K192720 | 000 |
| 10884521723450 | K192720 | 000 |