ApexMV
Stimulator, Electrical, Non-implantable, For Incontinence
InControl Medical, LLC
The following data is part of a premarket notification filed by Incontrol Medical, Llc with the FDA for Apexmv.
Pre-market Notification Details
| Device ID | K182022 |
| 510k Number | K182022 |
| Device Name: | ApexMV |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | InControl Medical, LLC 3225 Gateway Road Suite 250 Brookfield, WI 53045 |
| Contact | Corey Olson |
| Correspondent | Cory Olson InControl Medical, LLC 3225 Gateway Road Suite 250 Brookfield, WI 53045 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-27 |
| Decision Date | 2019-03-15 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851508007103 | K182022 | 000 |
Trademark Results [ApexMV]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 APEXMV 87952994 not registered Live/Pending |
InControl Medical, LLC 2018-06-07 |
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