The following data is part of a premarket notification filed by Covidien with the FDA for Signia Stapler (with New Software).
| Device ID | K201672 |
| 510k Number | K201672 |
| Device Name: | Signia Stapler (with New Software) |
| Classification | Staple, Implantable |
| Applicant | Covidien 60 Middletown Avenue North Haven, CT 06473 |
| Contact | Katherine Y Choi |
| 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 | 2020-06-19 |
| Decision Date | 2020-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521797437 | K201672 | 000 |