510(k) K062341
K062341 is an FDA 510(k) premarket notification submitted by Specialities Remeex International, S.L. for the device "MALE REMEEX SYSTEM". The FDA issued a decision of Substantially Equivalent on November 2, 2006. The device falls under product code OTM (Mesh, Surgical, For Stress Urinary Incontinence, Male), a Class II device regulated under 21 CFR 878.3300. Specialities Remeex International, S.L. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 2006
- Date Received
- August 10, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, For Stress Urinary Incontinence, Male
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- GU
- Submission Type
surgical treatment of male stress urinary incontinence post-prostatectomy