510(k) K020652
K020652 is an FDA 510(k) premarket notification submitted by Herniamesh for the device "HERNIAMESH T-SLING". The FDA issued a decision of Substantially Equivalent on May 15, 2002. The device falls under product code PAH (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling), a Class II device regulated under 21 CFR 878.3300. Herniamesh has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 2002
- Date Received
- Feb 28, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- GU
- Submission Type
- 510(k)
Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.