510(k) clearance
KIM BLUE
- 510(k) number
- K262284
- Applicant
- Desarrollo e Investigación Médica Aragonesa S.L.
- Decision date
- Oct 16, 2026
- Date received
- Jul 6, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OTN
- Device type
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- Device class
- Class II
- Regulation
- 21 CFR 878.3300
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Calatayud, ES