510(k) K042132
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2004
- Date Received
- August 9, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
Delivery of radio frequency energy to the submucosal tissue of the bladder neck and proximal urethra for the transurethral treatment of female stress urinary incontinence due to hypermobility.