ArcSP Suprapubic Sling System— 510(k) K222293

Substantially Equivalent

Urocure, LLC

FDA 510(k) clearance K222293 for ArcSP Suprapubic Sling System, Substantially Equivalent on 2022-09-21. Applicant: Urocure, LLC.

Clearance details

Applicant: Urocure, LLC
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2022-08-01
Decision date: 2022-09-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OTN

product code OTN

Injury: 6,630
Total: 6,630

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.