The following data is part of a premarket notification filed by Omniguide, Inc. with the FDA for Omniguide Beampath Oto-u Fiber.
| Device ID | K203241 |
| 510k Number | K203241 |
| Device Name: | OmniGuide BeamPath OTO-U Fiber |
| Classification | Powered Laser Surgical Instrument |
| Applicant | OmniGuide, Inc. 4 Maguire Road Lexington, MA 02421 |
| Contact | David Johnson |
| Correspondent | David Johnson OmniGuide, Inc. 4 Maguire Road Lexington, MA 02421 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-03 |
| Decision Date | 2021-01-14 |