The following data is part of a premarket notification filed by Bioness, Inc. with the FDA for Stimrouter Lead Kit/stimrouter Surgical Tool Kit/stimrouter Clinician Kit/stimrouter User Kit.
| Device ID | K142432 |
| 510k Number | K142432 |
| Device Name: | StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit |
| Classification | Stimulator, Peripheral Nerve, Implanted (pain Relief) |
| Applicant | BIONESS, INC. 25103 RYE CANYON LOOP Valencia, CA 91355 |
| Contact | Robert Schulz, Rac |
| Correspondent | Robert Schulz, Rac BIONESS, INC. 25103 RYE CANYON LOOP Valencia, CA 91355 |
| Product Code | GZF |
| CFR Regulation Number | 882.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-29 |
| Decision Date | 2015-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815962020306 | K142432 | 000 |
| 00815962020030 | K142432 | 000 |
| 00815962020023 | K142432 | 000 |
| 00815962020016 | K142432 | 000 |
| 00815962020313 | K142432 | 000 |
| 00815962020047 | K142432 | 000 |