The following data is part of a premarket notification filed by Covidien with the FDA for Signia Four-bay Smart Charger (to Be Used With Signia Stapler).
| Device ID | K170348 |
| 510k Number | K170348 |
| Device Name: | Signia Four-Bay Smart Charger (to Be Used With Signia Stapler) |
| 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 | 2017-02-03 |
| Decision Date | 2017-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521543850 | K170348 | 000 |