The following data is part of a premarket notification filed by Covidien, Formerly Us Surgical A Divison Of Tyco H with the FDA for Endo Gia Singleuse Duet Trs Reload With Tri0staple Technology.
| Device ID | K103263 |
| 510k Number | K103263 |
| Device Name: | ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY |
| Classification | Staple, Implantable |
| Applicant | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H 60 Middletown Ave North Haven, CT 06473 |
| Contact | Frank Gianelli |
| Correspondent | Frank Gianelli 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 | 2010-11-04 |
| Decision Date | 2010-11-22 |
| Summary: | summary |