510(k) K101169
K101169 is an FDA 510(k) premarket notification submitted by Caldera Medical, Inc. for the device "DESARA MESH MODEL: CAL-DS01". The FDA issued a decision of Substantially Equivalent on May 20, 2010. 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. Caldera Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2010
- Date Received
- April 26, 2010
- Clearance Type
- Special
- 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
Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility