510(k) K042132
K042132 is an FDA 510(k) premarket notification submitted by Novasys Medical, Inc. for the device "NOVASYS TRANSURETHRAL RF SYSTEM". The FDA issued a decision of Substantially Equivalent on December 21, 2004. The device falls under product code NVJ (Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women), a Class II device regulated under 21 CFR 878.4400. Novasys Medical, Inc. has at least 4 other 510(k) clearances on record.
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.