510(k) K052175
K052175 is an FDA 510(k) premarket notification submitted by Uroplasty, Inc. for the device "I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000". The FDA issued a decision of Substantially Equivalent on Oct 17, 2005. 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. Uroplasty, Inc. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 17, 2005
- Date Received
- Aug 10, 2005
- 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