510(k) K052025
K052025 is an FDA 510(k) premarket notification submitted by Uroplasty, Inc. for the device "URGENT PC NEUROMODULATION SYSTEM". The FDA issued a decision of Substantially Equivalent on Oct 17, 2005. The device falls under product code NAM (Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence), a Class II device regulated under 21 CFR 876.5310. Uroplasty, Inc. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 17, 2005
- Date Received
- Jul 27, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
- Device Class
- Class II
- Regulation Number
- 876.5310
- Review Panel
- GU
- Submission Type
- 510(k)