The following data is part of a premarket notification filed by Incontrol Medical, Llc with the FDA for Apexm.
| Device ID | K150183 |
| 510k Number | K150183 |
| Device Name: | ApexM |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | InControl Medical, LLC 3225 Gateway Road, Ste. 250 Brookfield, WI 53045 |
| Contact | Jessica Andreshak |
| Correspondent | Jessica Andreshak InControl Medical, LLC 3225 Gateway Road, Ste. 250 Brookfield, WI 53045 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-27 |
| Decision Date | 2015-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851508007097 | K150183 | 000 |
| 00851508007035 | K150183 | 000 |