The following data is part of a premarket notification filed by Nico Corporation with the FDA for Nico Brainpath.
| Device ID | K172433 |
| 510k Number | K172433 |
| Device Name: | NICO BrainPath |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | NICO Corporation 250 E 96TH St. Suite 125 Indianapolis, IN 46240 |
| Contact | Sean Spence |
| Correspondent | Sean Spence NICO Corporation 250 E 96TH St. Suite 125 Indianapolis, IN 46240 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-11 |
| Decision Date | 2017-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816744028333 | K172433 | 000 |
| 10816744028326 | K172433 | 000 |
| 10816744028319 | K172433 | 000 |
| 00816744028305 | K172433 | 000 |
| 00816744027384 | K172433 | 000 |
| 00816744027377 | K172433 | 000 |
| 00816744027360 | K172433 | 000 |
| 00816744027353 | K172433 | 000 |
| 10816744038455 | K172433 | 000 |