ArcTV Transvaginal Sling System— 510(k) K183134
Substantially EquivalentUrocure, LLC
FDA 510(k) clearance K183134 for ArcTV Transvaginal Sling System, Substantially Equivalent on 2019-02-07. Applicant: Urocure, LLC. Device class: 2.
Clearance details
- Applicant
- Urocure, LLC
- 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
Recent devices under product code OTN
view all- K231549 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
- K222293 — ArcSP Suprapubic Sling System
- K222468 — ArcTO Transobturator Sling System
- K211975 — Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
- K211223 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
Adverse 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.