The following data is part of a premarket notification filed by Lexington Medical, Inc. with the FDA for Aeon Laparoscopic Instruments.
| Device ID | K192235 |
| 510k Number | K192235 |
| Device Name: | AEON Laparoscopic Instruments |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Lexington Medical, Inc. 11 Executive Park Drive Billerica, MA 01862 |
| Contact | Douglas Macbride |
| Correspondent | Douglas Macbride Lexington Medical, Inc. 11 Executive Park Drive Billerica, MA 01862 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-19 |
| Decision Date | 2019-10-11 |
| Summary: | summary |