The following data is part of a premarket notification filed by Covidien, Formerly Us Surgical A Divison Of Tyco H with the FDA for Idrive Ultra Powered Handle And Endo Gia Adapter.
| Device ID | K123318 |
| 510k Number | K123318 |
| Device Name: | IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER |
| Classification | Staple, Implantable |
| Applicant | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H 60 Middletown Ave North Haven, CT 06473 |
| Contact | Sarah Rizk |
| Correspondent | Sarah Rizk COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H 60 Middletown Ave 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 | 2012-10-25 |
| Decision Date | 2012-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521144408 | K123318 | 000 |