The following data is part of a premarket notification filed by Cadwell with the FDA for Cadwell Disposable Probe Handle.
| Device ID | K123589 |
| 510k Number | K123589 |
| Device Name: | CADWELL DISPOSABLE PROBE HANDLE |
| Classification | Neurosurgical Nerve Locator |
| Applicant | CADWELL 909 N. KELLOGG ST. Kennewick, WA 99336 |
| Contact | Chris Bolkan |
| Correspondent | Chris Bolkan CADWELL 909 N. KELLOGG ST. Kennewick, WA 99336 |
| Product Code | PDQ |
| Subsequent Product Code | ETN |
| Subsequent Product Code | GXZ |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-21 |
| Decision Date | 2013-03-19 |
| Summary: | summary |