510(k) K141158
K141158 is an FDA 510(k) premarket notification submitted by Incontrol Medical, LLC for the device "APEX". The FDA issued a decision of Substantially Equivalent on Nov 26, 2014. 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
- SESE (Substantially Equivalent)
- Decision Date
- Nov 26, 2014
- Date Received
- May 5, 2014
- 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)