The following data is part of a premarket notification filed by Surgical Devices, A Divsion Of Tyco Healthcare with the FDA for Autosuture Endo Gia Single Use Black Reload With Tri-staple Technology.
| Device ID | K093410 |
| 510k Number | K093410 |
| Device Name: | AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY |
| Classification | Staple, Implantable |
| Applicant | SURGICAL DEVICES, A DIVSION OF TYCO HEALTHCARE 60 MIDDLETOWN AVE. North Haven, CT 06473 |
| Contact | Frank Gianelli |
| Correspondent | Frank Gianelli SURGICAL DEVICES, A DIVSION OF TYCO HEALTHCARE 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 | 2009-11-02 |
| Decision Date | 2009-11-12 |
| Summary: | summary |