510(k) K182022
K182022 is an FDA 510(k) premarket notification submitted by Incontrol Medical, LLC for the device "ApexMV". The FDA issued a decision of Substantially Equivalent - Kit on Mar 15, 2019. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Incontrol Medical, LLC has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent - Kit)
- Decision Date
- Mar 15, 2019
- Date Received
- Jul 27, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Non-Implantable, For Incontinence
- Device Class
- Class II
- Regulation Number
- 876.5320
- Review Panel
- GU
- Submission Type
- 510(k)