510(k) K103418
K103418 is an FDA 510(k) premarket notification submitted by Caldera Medical, Inc. for the device "DESARA MINI". The FDA issued a decision of Substantially Equivalent on November 30, 2011. 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. Caldera Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 2011
- Date Received
- November 22, 2010
- 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
Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.