I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000— 510(k) K052175
Substantially EquivalentUroplasty, Inc.
FDA 510(k) clearance K052175 for I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000, Substantially Equivalent on 2005-10-17. Applicant: Uroplasty, Inc.. Device class: 2.
Clearance details
- Applicant
- Uroplasty, Inc.
- Product code
- Code OTN
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
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More clearances from Uroplasty, Inc.
view allAdverse events under product code OTN
product code OTN- Injury
- 6,630
- Total
- 6,630
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.