The following data is part of a premarket notification filed by Covidien with the FDA for Covidien Endo Gia Radial Reload With Tri-staple Technology.
| Device ID | K102291 |
| 510k Number | K102291 |
| Device Name: | COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY |
| Classification | Staple, Implantable |
| Applicant | COVIDIEN 60 MIDDLETOWN DR North Haven, CT 06473 |
| Contact | Tim M Lohnes |
| Correspondent | Tim M Lohnes COVIDIEN 60 MIDDLETOWN DR 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 | 2010-08-12 |
| Decision Date | 2010-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521141749 | K102291 | 000 |