The following data is part of a premarket notification filed by Covidien Lp, Formerly Registered As United States with the FDA for Autosuture Endo Gia Staplers With Endo Gia Single Use Loading Units.
| Device ID | K083519 |
| 510k Number | K083519 |
| Device Name: | AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS |
| Classification | Staple, Implantable |
| Applicant | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Contact | Frank Gianelli |
| Correspondent | Frank Gianelli COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-26 |
| Decision Date | 2009-04-10 |
| Summary: | summary |