The following data is part of a premarket notification filed by Lexington Medical Inc. with the FDA for Aeon Endoscopic Stapler.
| Device ID | K201882 |
| 510k Number | K201882 |
| Device Name: | AEON Endoscopic Stapler |
| Classification | Staple, Implantable |
| Applicant | Lexington Medical Inc. 11 Executive Park Drive Billerica, MA 01862 |
| Contact | Rainer Maas |
| Correspondent | Rainer Maas Lexington Medical Inc. 11 Executive Park Drive 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 | 2020-07-08 |
| Decision Date | 2020-10-09 |