The following data is part of a premarket notification filed by Surgical Devices, A Global Business Unit Tyco with the FDA for Autosuture Endo Gia Single Use Tan Reload With Tri-staple Technology.
| Device ID | K101444 |
| 510k Number | K101444 |
| Device Name: | AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY |
| Classification | Staple, Implantable |
| Applicant | SURGICAL DEVICES, A GLOBAL BUSINESS UNIT TYCO 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Contact | Frank Gianelli |
| Correspondent | Frank Gianelli SURGICAL DEVICES, A GLOBAL BUSINESS UNIT TYCO 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 | 2010-05-24 |
| Decision Date | 2010-06-14 |
| Summary: | summary |