The following data is part of a premarket notification filed by Image-guided Neurologics, Inc. with the FDA for Navigus Ii Trajectory Guide.
| Device ID | K012366 |
| 510k Number | K012366 |
| Device Name: | NAVIGUS II TRAJECTORY GUIDE |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | IMAGE-GUIDED NEUROLOGICS, INC. 2290 W. EAU GALLIE BLVD. SUITE 210 Melbourne, FL 32935 |
| Contact | David M Lee |
| Correspondent | David M Lee IMAGE-GUIDED NEUROLOGICS, INC. 2290 W. EAU GALLIE BLVD. SUITE 210 Melbourne, FL 32935 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-26 |
| Decision Date | 2001-10-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994289650 | K012366 | 000 |
| 00613994289643 | K012366 | 000 |
| 00613994289636 | K012366 | 000 |
| 00613994289629 | K012366 | 000 |
| 00613994289612 | K012366 | 000 |
| 00643169214828 | K012366 | 000 |
| 00643169214811 | K012366 | 000 |
| 00643169214804 | K012366 | 000 |
| 20613994747888 | K012366 | 000 |