The following data is part of a premarket notification filed by Covidien Llc with the FDA for Endo Gia(tm) Extra Long Adapter.
| Device ID | K133762 |
| 510k Number | K133762 |
| Device Name: | ENDO GIA(TM) EXTRA LONG ADAPTER |
| Classification | Staple, Implantable |
| Applicant | Covidien LLC 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Contact | Debra Peacock |
| Correspondent | Debra Peacock Covidien LLC 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 | 2013-12-11 |
| Decision Date | 2014-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521201989 | K133762 | 000 |