The following data is part of a premarket notification filed by Lexington Medical Inc. with the FDA for Aeon Endoscopic Stapler.
| Device ID | K171589 |
| 510k Number | K171589 |
| Device Name: | AEON Endoscopic Stapler |
| Classification | Staple, Implantable |
| Applicant | Lexington Medical Inc. 11 Executive Park Dr. Billerica, MA 01862 |
| Contact | Donna Gasper |
| Correspondent | Donna Gasper Lexington Medical Inc. 11 Executive Park Dr. Billerica, MA 01862 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-31 |
| Decision Date | 2017-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851574008868 | K171589 | 000 |
| 00851574008721 | K171589 | 000 |
| 00851574008660 | K171589 | 000 |
| 00851574008080 | K171589 | 000 |
| 00851574008066 | K171589 | 000 |
| 00851574008028 | K171589 | 000 |
| 00851574008004 | K171589 | 000 |
| 00851574008981 | K171589 | 000 |
| 00851574008134 | K171589 | 000 |