510(k) K262284
K262284 is an FDA 510(k) premarket notification submitted by Desarrollo E Investigación Médica Aragonesa S.L. for the device "KIM BLUE". The FDA issued a decision of Substantially Equivalent on Oct 16, 2026. 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.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 16, 2026
- Date Received
- Jul 6, 2026
- 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