510(k) K101847
K101847 is an FDA 510(k) premarket notification submitted by Uroplasty, Inc. for the device "URGENT PC STIMULATOR; URGENT PC LEAD SET". The FDA issued a decision of Substantially Equivalent on October 21, 2010. 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 at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2010
- Date Received
- July 1, 2010
- 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