The following data is part of a premarket notification filed by Omniguide, Inc. with the FDA for Flexguide Ultra Beampath Robotic Fiber Conduit.
| Device ID | K140378 |
| 510k Number | K140378 |
| Device Name: | FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT |
| Classification | Powered Laser Surgical Instrument |
| Applicant | OMNIGUIDE, INC. ONE KENDALL SQUARE SUITE B1301 Cambridge, MA 02139 |
| Contact | Nicole Rasmussen |
| Correspondent | Nicole Rasmussen OMNIGUIDE, INC. ONE KENDALL SQUARE SUITE B1301 Cambridge, MA 02139 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-14 |
| Decision Date | 2014-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00894338002818 | K140378 | 000 |