510(k) K050516
K050516 is an FDA 510(k) premarket notification submitted by Herniamesh S.R.L. for the device "T-SLING". The FDA issued a decision of Substantially Equivalent on Feb 3, 2006. The device falls under product code OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator), a Class II device regulated under 21 CFR 878.3300. Herniamesh S.R.L. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 3, 2006
- Date Received
- Mar 1, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- GU
- Submission Type
- 510(k)
Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility